Abstracts

. 2019 Mar;25(Suppl 1):S1–S39.

Abstracts

PMCID: PMC6436397

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/01: NONALCOHOLIC FATTY LIVER DISEASE IN LEAN AND OBESE PATIENTS: IMAGING, RISK FACTORS AND CORRELATIONS

Faris Althunayyan ¹, Ali Alsudays ¹, Badr Aljarallah ¹, Khalid A Alsuhaibani ¹

Background: Fatty liver is a disease caused by accumulation of fat in the liver. It is one of the major risk factors for developing cirrhosis and hepatocellular carcinoma. Saudi Arabia is one of the most prevalent country in diabetes and obesity. Overall prevalence of diabetes is 23.7% and obesity is 35.6%. There are many predisposing factors established to be a cause of fatty liver such obesity, sedentary life and others. But still are not all the causes are known yet. Aim: To study the correlation between fatty liver finding on abdominal Ultrasound (US) and their clinical and biochemical profile including BMI, blood glucose level, lipid profile, liver function tests and blood pressure in both group lean and obese patients.

Methods: Cross sectional study of a total of three hundred and forty-six (346) fatty liver ultrasound sound proven patients were enrolled in the study from January – May 2016 in King Saud Hospital, Qassim, Saudi Arabia.

Results: Mean age of participants was 50.3 years. Female participants are 55% of the cohort. Participants divided based on their BMI. BMI < 25 (lean), BMI from 25-30 (overweight and mild obesity) and BMI >30 (morbid obesity). We found that Cholesterol (p-value 0.007) and LDL (p-value 0.015) were higher in lean compared to other (5 and 3.1), respectively. GGT was higher in mild obese patients (113.2) and ALT which was higher in lean patients (60.4). 34.5% of the overall patients had Diabetes Mellitus (DM). We found that HbA1c was lower in lean (7.3) compared to morbidly obese patients (7.6). Platelets counts was higher in morbidly obese patients (278) compared to other groups.

Conclusion: High cholesterol and LDL strongly correlated with the lean fatty liver patients. There was significant relationship between female gender and the risk of development of fatty liver. However, Liver enzymes were within the normal range except GGT which was higher in all the groups with highest value in mild obese patients. Therefore, they are not sensitive for diagnosing fatty liver patients.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/02: THE SAFETY OF ENDOSCOPIC MUCOSAL BIOPSIES IN PATIENTS RECEIVING DIRECT ORAL ANTICOAGULANTS

Zaki Alhashimalsayed ¹, Turki Alameel ¹

Background: Current Asian endoscopic societies guidelines advise against stopping direct oral anticoagulants (DOACs) in low risk endoscopic procedures. This is defined as mucosal biopsies without cutting open the mucosa or breaching the deep layers. However, Western societies such as the British Society of Gastroenterology (BSG) and European Society of Gastrointestinal Endoscopy (ESGE) recommend omitting the morning dose of DOACs on the day of procedure if biopsy is planned. Both guidelines have weak recommendation with low quality evidence. In this study our aim is to evaluate the safety of endoscopic biopsy in patients who are taking DOACs.

Methods: This study is a retrospective observational study done at a single institution. It included patients who were taking DOACs and underwent endoscopic procedure with mucosal biopsies at King Fahad Specialist Hospital in Dammam between the period of 2013 to 2017. We retrospectively evaluated patients’ electronic records. Significant bleeding was defined as bleeding leading to unplanned emergency department visit, unplanned hospital admission, and/or blood transfusion requirement within 2 weeks of endoscopic mucosal biopsy. Patient taking DOACs at the day of endoscopy has been confirmed by electronic ordering system and pre-endoscopy assessment sheet completed by health care providers on the day of the procedure.

Results: Among 65 patients undergoing endoscopic mucosal biopsies who were on DOAC, nine patients received DOAC on the day of procedure. Biopsies were performed for five patients who underwent esophagogastroduodenoscopy, one patient had colonoscopy and three patients had both procedures. DOAC included rivaroxaban in eight patients and one patient on apixaban. None of these patients required unplanned emergency department visit, unplanned hospital admission, and/or blood transfusion within 2 weeks after the endoscopic mucosal biopsy.

Conclusion: Endoscopic mucosal biopsy without cessation of direct oral anticoagulants appears to be safe. However, larger volume studies are needed to confirm this.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/03: COST-EFFECTIVENESS OF COLORECTAL CANCER SCREENING IN A LOW INCIDENCE COUNTRY: THE EXAMPLE OF SAUDI-ARABIA

Steffie K Naber ¹, Majid A Almadi ¹, Gordon Guyatt ², Feng Xie ^2,³, Iris Lansdorp-Vogelaar ¹

Background: Although colorectal cancer (CRC) is the most common cancer among males in Saudi Arabia, the incidence is low compared to European countries and the US. This study evaluates the cost-effectiveness of CRC screening in Saudi-Arabia.

Methods: We used the MISCAN model to evaluate different screening programs for a hypothetical cohort of 1000 45-year-old Saudi-Arabian males. First, the model was adjusted to the life-expectancy, age-specific CRC incidence, CRC stage distribution, and stage-specific mortality rates observed in Saudi-Arabian males. Second, we simulated four different screening strategies; once-only colonoscopy at age 45, 10-yearly colonoscopy at ages 45-75, annual fecal immunochemical testing (FIT) at ages 45-75, and biennial FIT at ages 45-75. Costs and quality-adjusted life years (QALYs) were obtained from the local context, both discounted at an annual rate of 3%.

Results: In the absence of screening, the model predicted 14 CRC cases and 9 CRC deaths at a total cost of $446,000. Biennial FIT prevented 5 of these cases and 5 of these deaths, thereby resulting in 16 QALYs gained at an incremental cost of $318,000. Annual FIT prevented two more cases and one more death, yielding 7 more QALYs gained at an incremental cost of $254,000. Biennial FIT had an incremental cost-effectiveness ratio (ICER) of $20,000 compared to no screening, and annual FIT of $36,000 compared to biennial FIT. Once only-colonoscopy was dominated by FIT screening, and 10-yearly colonoscopy had an ICER of $496,000 compared to annual FIT.

Conclusion: The optimal strategy depends on the willingness-to-pay threshold, which is yet to be determined for Saudi-Arabia.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/04: PATTERN OF PEDIATRIC GASTROINTESTINAL DISEASE AT REFERRAL HOSPITALS IN MAKAH CITY (2015-2017)

Ali Alshamrani ¹, Abdulwahab Telmesani ¹, Ahmad Almehmadi ¹, Hana Halabi ¹, Abdulah Alshanbari ¹

Background: Retrospective studies are important for reassessment of patient flow paradigm, efficacy of preventive methods and re-planning of medical service in health care providing institutes.

Aim: Determination of epidemiology of gastroenterological diseases among children and methods of prevention.

Patients and Methods: This is a retrospective study on 333 pediatric G.I patients seen at an (OPD and admission patients) done at a referral hospitals at Makah city (2015- 2017).

Results: There was no bias in male-to-female selection and ratio was mirroring population data. Those below three months ratio were less than 10% of cases and most of the cases complaining of congenital diseases. Chronic constipation was the most prevalent GI disease followed by inflammatory bowel diseases and regurgitation syndrome.

Conclusion: This study enabled us to plan well for the care of the pediatric gastrointestinal disease at the city of Makah. It will alert the directory of the ministry of health to launch an appropriate health education for the people of Makah regarding the prevention of common problems like constipation which consume good proportion of the pediatric gastroenterology clinic time. To educate the general pediatrician how to deal with simple common G.I disease (i.e. chronic constipation), how to treat it and the referral to G.I is only for the resistant cases.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/05: PREDICTIVE FACTORS FOR CIRRHOSIS IN CHRONIC HBV MONO-INFECTION COMPARED TO HBV/HDV, AND HBV/HCV CO-INFECTION

Raja Omer ¹, Muhammad Omar ¹, Ommara Jamil ¹, Farooq Hanif ¹, Usman Ghani ¹, Abdul Nadir ¹

Background: Risk factors for chronic HBV cirrhosis include age, HbeAg positivity, increased ALT, co-infection with the HDV and HBV viral load >20,000 IU/ml. The aim was to investigate virological and biochemical characteristics of patients with HBV mono, HBV/HCV and HDV/HBV co-infections; and determine risk factors for cirrhosis.

Methods: 586 HBV positive patients. anti-HCV and anti-HDV positive identified. Cirrhosis based on APRI >1.5 or/and Fib4 ≥1.45; or/and F4 on Fibroscan. HBV-DNA level <2,000 IU and?>20,000 IU, labeled patients with low and high viral load respectively.

Results: 52% mono-infected with HBV, 75% had HBV/HCV, and 25% had HBV/HDV. 24% were cirrhotic. Highest rate of cirrhosis in HBV/HDV (56%). Age was an independent risk factor for HbsAg positive cirrhotic P < 0.001. HBV/HDV co-infected cirrhotic were younger compared to the other groups; p=0.003). Low HbsAg levels strongly correlated with low HBV DNA levels <2,000 IU/ml in all groups (P<0.001). Raised ALT levels were predictive of cirrhosis in HBV mono-infected and HBV/HCV co-infected cirrhotic; p<0.05. BMI>30 was an independent predictor (OR=1.49; CI=.4-5.6; p=0.04) of cirrhosis for only HBV mono-infected patients.

Conclusion: High BMI need to be addressed among HBV mono-infected patients. No correlation between HBV viral load in co-infected HCV and HDV patients might indicate that HCV and HDV are dominant in causing hepatic fibrosis. Low HBsAg can be used in lieu of HBV-DNA levels to reduce costs.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/06: OVERWEIGHT AND OBESITY AMONG SAUDI CHILDREN AND ADOLESCENTS: WHERE DO WE STAND TODAY?

Abdulrahman Al-Hussaini ¹, Mouhammad Salman Bashir ¹, Musa Khormi ², Muath AlTuraiki ³, Wahid Alkhamis ⁴, Mona Alrajhi ⁴, Thana Halal ⁴

Background: To provide the most recent estimate of childhood obesity and determine the trend in childhood obesity in Riyadh city over the past 2 decades by comparing our results with previous studies that published data comparable to our study in terms of geography, sample age (6-16 years), and use of World Health Organization (WHO) cut offs to define obesity.

Materials and Methods: A cross-sectional study was conducted in 2015 among school children in Riyadh city. A sample of 7930 children (67% girls) aged 6-16 years were randomly selected. Body mass index (BMI) for age and gender above +1 and below + 2 standard deviation scores defined overweight (SDS, z scores) and > + 2 standard deviation scores defined obesity.

Results: The overall prevalence of overweight and obesity was 13.4% (14.2% for girls and 12 % for boys; P-value = 0.02) and 18.2% (18% for girls and 18.4% for boys; P-value = 0.73), respectively. When compared to the WHO-based national prevalence rate of obesity reported in 2004 (≈ 9.3%), the obesity rate has doubled over a 10-year period. There was a significantly higher prevalence of obesity in adolescents (> 11 years) than in children (20.2% versus 15.7%; P< 0.01). Overweight and obesity increased significantly with higher levels of socio-economic status. Obese children were at 1.5 and 2 times risk of developing gas bloating and vomiting than non-obese children.

Conclusion: The prevalence of overweight and obesity is alarmingly rising among Saudi children and adolescents over the past decade and should make a strong case to initiate and monitor effective implementation of obesity prevention measures.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/07: WHERE ARE WE TODAY WITH HELICOBACTER PYLORI INFECTION AMONG HEALTHY CHILDREN IN SAUDI ARABIA?

Abdulrahman A Al-Hussaini ¹, Abdullah N Al-Jurrayyan ¹, Salman Bashir ², Dayel Alshahrani ³

Background: The available studies on Helicobacter pylori (H. pylori) prevalence among healthy asymptomatic population across Saudi Arabia suffered from significant limitations. We conducted this large population based study to estimate the H. pylori infection rate among healthy children in Saudi Arabia, using anti-H. pylori IgA and IgG serology tests, and to study the influence of H. pylori infection on growth.

Methods: We conducted a cross-sectional study to screen healthy asymptomatic school aged Saudi children (aged 6-15 years), attending primary and intermediate schools in Riyadh between 2014 and 2016, for H. pylori infection by checking for the presence of anti-H. pylori IgG and IgA antibodies in serum specimens.

Results: Out of 3551 serum specimens, 1413 cases tested positive for H. pylori infection (≈ 40%): 430 (12.2%) were both IgG and IgA positive, 212 (6%) and 771 (21.7%) cases showed isolated positivity for IgG or IgA, respectively. Male gender, older age, lower levels of SES, and family members >10 were significantly associated with H. pylori seropositivity. The proportion of participants with short stature was significantly more in the H. pylori seropositive group than the seronegative group (OR1.249, CI [1.020 – 1.531], P =0.033). There was no significant association between H. pylori infection and gastrointestinal symptoms.

Conclusion: The prevalence of H. pylori infection among the healthy Saudi children (40%) is intermediate compared with that in developed and developing countries. The Saudi pediatric population shows a predominant IgA-type immunological response to H. pylori infection.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/08: WHAT DO SAUDI CHILDREN INGEST? A 10-YEAR RETROSPECTIVE ANALYSIS OF INGESTED FOREIGN BODIES FROM A TERIARY CARE CENTER

Ahmed H Ibrahim ¹, Abdurahman Andijani ¹, Muhammed Abdulshakou ¹, Sulwan Algain ¹, Asma Abu Thamrah ¹, Mariam M Ali ¹, Haifa Marwah ¹, Anwar Aldahir ¹, Salman Bashir ¹, Bader Alsaleem ², Ali Asery ², Abdulrahman Al-Hussaini ²

Background: Few studies investigated the correlation between foreign body (FB) ingestion and occurrence of complications. The local literature is limited to case reports and small case series on esophageal FBs. We conducted this study to identify the high risk factors predisposing to complications among Saudi children ingesting FBs.

Methods: The medical records of 436 children [boys 59.6%, mean age 4.4 years ± 2.7 years] presenting to the emergency room (ER) between 2007 and 2016 were retrospectively reviewed. Relative risk analysis of clinical variables was performed between 2 groups: The first group constituted children without FB-related complications (n=389) and the second group included those with major complications (n=14). Major complication was defined as any event associated with significant morbidity such as esophageal stricture, esophageal perforation, esophageal fistula, and intestinal perforation or fistula formation.

Results: The majority of the 436 cases presented between ages 2 to 4 years (35.1%). Coin was the most commonly ingested FB (22.9%) followed by button battery (19.5%). Majority of the ingested FBs passed spontaneously without intervention (69%). Upper endoscopy was performed in 121 cases (27.7%). By multivariate analysis, the variables that were significantly associated with major complications included: very young age group (0-2 years, Odds ratio [OR]= 11.5), button battery (OR= 4), FB impacted at upper esophagus (OR = 8.7), and longer time duration to visit ER (OR = 14.7).

Conclusion: Button battery impaction at upper esophagus in very young children and delayed presentation to ER were the most significant risk factors of FB-related complications.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/09: HLA-DQ GENOTYPES RISK FOR CELIAC DISEASE AMONG SAUDI CHILDREN: A CASE-CONTROL STUDY

Abdulrahman Al-Hussaini ¹, Nezar Eltayeb-Elsheikh ¹, Hanan Alharthi ¹, Awad Osman ¹, Maram Alshahrani ¹, Ibrahim Sandogji ¹, Sami Alrashidi ¹, Muhammed Salman Bashir ²

Background: Recently, it has become apparent that the prevalence of celiac disease (CD) in Saudi Arabia (1.5%) is greater than that found in most of the European countries (1%). This has raised the questions, is the Saudi population genetically susceptible to develop CD? And what degree of risk is conferred by the HLA-DQ genotypes among Saudi children as compared to Caucasians. In this study, we aimed to answer these questions.

Methods: We recruited two groups: group I, 100 CD children diagnosed consecutively over the past 10 years, and group II, 192 healthy controls with negative celiac profile randomly selected from primary and intermediate schools. All the participants were typed for the DQA1 and DQB1 genes by polymerase chain reaction sequence-specific oligonucleotide probes.

Results: Comparing the CD patients to controls, we identified 5 groups in the CD risk gradient: 1) very high risk associated with the DQ2.5/DQ8 genotype [odds ratio (OR) = 47]; 2) high risk (homozygous DQ2.5, DQ2.5/DQ2.2; OR = 4-5); 3) intermediate risk (heterozygous DQ2.5, DQ8/DQ2.2; OR = 1.6); 4) low risk (DQ8, DQ2.2), and 5) very low risk (DQ2.x, DQX.5, DQX.x). Thirty nine percent of the healthy controls are at increased risk to develop CD (homozygous DQ2.5 in 2.6%, DQ2.5/DQ2.2 in 4.7%, DQ8/DQ2.2 in 3.6%, and heterozygous DQ2.5 in 28%).

Conclusion: Saudi population is at 39% risk to develop CD, which might explain the high prevalence of CD in the Saudi community. The highest risk of developing CD in Saudi Arabia is associated with the DQ2.5/DQ8 genotype. We provided additional evidence that there is a definite “gene dosage effect,” highlighting the impact of detailed HLA typing in detecting individuals who are potentially at risk for CD.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/10: STATUS OF VITAMINS AND TRACE ELEMENTS IN CHILDREN WITH SCREENING-IDENTIFIED CELIAC DISEASE: A CASE-CONTROL STUDY

Abdulrahman Abdullah Al-Hussaini ^1,², Muhammed Salman Bashir ³

Background: Malabsorption and micronutrients deficiencies characterize classical “late diagnosed” celiac disease (CD). This study aimed to identify the prevalence of vitamin and mineral deficiencies among children with screening-identified CD in comparison to healthy controls to determine whether there is any clinical value in routine testing for deficiencies in those patients.

Methods: A case-control study was conducted on patients with screening-identified CD diagnosed during a mass screening study [2014 to 2016] (100 patients, 79 females, mean age 11.4 ± 2.7 years) and age and gender-matched healthy controls (100 children, 81 females, mean age 10.8 ± 2.5 years). The controls were randomly selected from those who were negative for CD serological screening. Hemoglobin, serum levels of iron, ferritin, folate, vitamin B12, vitamin A, vitamin E, 25-OH vitamin D, zinc, and selenium were measured.

Results: Mean hemoglobin and serum iron level were significantly lower in CD patients as compared to healthy controls [Hemoglobin 12.56 gm/dl versus 13.07 gm/dl (P= 0.024); Iron 10.61 µmol/L versus 13 µmol/L (P =0.009), respectively]. The serum levels of vitamins and trace elements were similar between the 2 groups. There was significant negative correlation between levels of hemoglobin, iron, and ferritin at diagnosis and serum TTG-IgA titers (Pearson’s correlation coefficient -0.182, P-value = 0.021). There was significant positive correlation between levels of hemoglobin, iron, and ferritin at diagnosis and the degree of villous atrophy (P-value = 0.033).

Conclusion: Iron deficiency is the earliest micronutrients deficiency to develop in screening-identified CD cases; the level of serum iron is correlated with the TTG-IgA titer and degree of villous atrophy.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/11: AUTOIMMUNE HEPATITIS PREVELANCE AMONG PATIENTS WITH CHRONIC LIVER DISEASE FROM SAUDI ARABIA

Rajaa Alshanketi ¹, Reem Jabad ¹, Bayan Baghlaf ¹, Romaysaa Alyamani ¹, Majed Alsahafi ¹, Hisham Akbar ¹, Hind Fallatah ¹

Background: Autoimmune hepatitis (AIH) is a chronic liver disease that can lead to progressive liver damage. The prevalence of AIH among general population and among chronic liver disease (CLD) patients is variable worldwide. Currently no published data on the prevalence of AIH among Saudis or in the Middle east. Our aim is to study the prevalence of AIH among CLD patients from Saudi Arabia.

Methods: Retrospective study of CLD patients who had transient elastography (fibroscan) during the 3 year study period. For all patients we obtained demographic data, laboratory test for ALT, Bilirubin, Hg, platelets, INR. We compared the result of AIH patients with non AIH patients with CLD. For AIH we also obtained serum IgG, ANA, SMA and ALT at 2-6 weeks and 3-4 month.

Results: We included 494 patients. They were predominantly females 271 (60%) and Saudis 299 (60.5%). Thirty patients (6.1%) had AIH. Compare to non-AIH patients, AIH patients were younger 49.9 SD 14.22 and 40.4 SD13.94 respectively P=.001. AIH had significantly lower Hg and platelets P= .008 for both. They also had higher ALT, Bilirubin and INR p=.05, .047 and .019, respectively. More than 50% (16) of AIH patients had cirrhosis. Older age is associated with advance disease among none AIH patient P< 001.

Conclusion: AIH represent the 4^th most common liver disease among CLD patients from Saudi Arabia. It is associated with sever disease activity at relatively young age, with remarkable biochemical response to steroids and azathioprine.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/12: PUBLIC AWARENESS OF HEPATITIS B AND C INFECTIONS IN SAUDI ARABIC: AN INTERNET-BASED SURVEY

Raghad Aldehasi ¹, Almoutaz Hashim ¹, Asma Alshehri ¹, Ghala Aljedaani ¹, Mahmoud Mosli ¹

Background: Chronic viral hepatitis is a global health care problem. HBV and HCV infections are highly prevalent in the Kingdom of Saudi Arabia (KSA). It is therefore crucial that the community is aware of symptoms, risk factors and consequences of carrying chronic infection with hepatitis B (HBV) or hepatitis C (HCV) viruses. We therefore aimed to study the level of awareness among the Saudi community about HBV and HCV infection.

Methods: We conducted an internet-based cross-sectional survey targeting adult Saudi individuals. Closed ended questions were used to evaluate awareness and knowledge of the participants about risk factors, symptoms, and sequelae of HBV and HCV infections.

Results: A total of 5029 individuals were surveyed of which 62% were between 36-60 years of age, and 67% were females. 21% reported having a family member with chronic viral hepatitis and 7% were personally infected with HBV (6%) or HCV (1%). When asked about risk factors for HBV and HCV infections, 59% and 47% chose “blood transfusion”, 47% and 37% chose “sharing personal hygiene tools”, 41% and 41% chose “using contaminated needles”, and 24% and 34% responded by “I don’t know”, respectively. Of the total cohort, 68% did not know about HBV vaccination, and 33% thought that a vaccine against HCV is available.

Conclusions: Despite the high prevalence of HBV and HCV infections in KSA, there seems to be large gap in knowledge observed in the community. Efforts to improve public knowledge and awareness of HBV and HCV infections in KSA are needed.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/13: LIVER FIBROSIS IN PATIENTS WITH OBSTRUCTIVE SLEEP APNEA: A RETROSPECTIVE ANALYSIS

Hani Jawa ¹, Hazim Khatib ¹, Faris Alhejaili ¹, Siraj Wali ², Mahmoud Mosli ¹, Naif Alzahrani ¹, Ahmed Alawi ¹, Mohand Alghamdi ¹, Ahmed Abuljadayel ²

Background: Obstructive sleep apnea (OSA) and non-alcoholic fatty liver disease (NAFLD) are globally prevalent medical conditions associated with significant morbidity. An association between these two conditions has been recently established. We therefore aimed to estimate the prevalence of radiologically defined NAFLD and identify possible predictors of high fibrosis scores and NAFLD in a cohort of patients with OSA.

Materials and Methods: We performed a retrospective study that included all patients seen in the outpatient department at King Abdulaziz University Hospital, Jeddah, Saudi Arabia between January 2016 and August 2018 with confirmed OSA (Apnea Hypopnea Index (AHI) >5) who underwent abdominal ultrasonography. Clinical, biochemical and radiologic findings, were recorded. OSA severity was assessed using the AHI and NAFLD severity using the NAFLD fibrosis score (NFS) and Fibrosis-4 score (FIB-4). The primary outcome of the study was the prevalence of radiologically defined NAFLD (defined as hepatic steatosis seen on abdominal ultrasound). Secondary outcomes included prevalence of liver cirrhosis according to ultrasound, elevated liver enzymes, NFS>0.676 and FIB-4 >2.67, and factors predictive of high NFS and FIB-4, and NAFLD. A standard formula was used to calculate prevalence and logistic regression analysis was used to identify predictors of categorical outcomes. Odds ratios (OR) were generated.

Results: 133 patients fulfilled study inclusion criteria. Average age was 49.8±15.1 and 57.1% were females. 37.6%, 32.3% and 12.8%, had hypertension, diabetes, and dyslipidemia, respectively. Average BMI was 37.3±14.5. According to AHI scores, 37.9%, 29.6%, and 32.6% had mild (5-15), moderate (15-30), and severe (>30) OSA. 16.5% of patients were treated with CPAP. Radiologically defined NAFLD was detected in 44.4%, liver cirrhosis in 3%, and elevated liver enzymes in 63.9% of patients. High NFS and FIB-4 were recorded in 9% and 3.8% of patients. Age (OR=1.1, p=0.018), liver cirrhosis (OR=1326, p=0.008), and BMI (OR=1.2, p=0.009) significantly predicted high NFS scores, and liver cirrhosis (OR=62.5, p=0.047) predicted high FIB-4 scores. Significant predictors of NAFLD were not identified statistically.

Conclusions: A significant proportion of patients with OSA have NAFLD. Age, body mass, and presence of liver cirrhosis might be predictive of image-dependent NAFLD scores.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/14: INCIDENCE RISK AND CORRELATIONS BETWEEN EXTRA INTESTINAL MANIFESTATIONS OF INFLAMMATORY BOWEL DISEASE IN MIDDLE EASTERN DESCENDANTS

Heba Adam ¹, Maryam Alqassas ¹, Omar Saadah ¹, Mahmoud Mosli ¹

Background: Crohn’s disease (CD) and Ulcerative colitis (UC), are gastrointestinal disorders with many extra-intestinal manifestations (EIMs). The prevalence of EIMs reportedly occurs in 10- 50% of IBD patients. The large variation in occurrence of EIMs has been linked with genetic predisposition. Correlations between EIMs are unclear. We aim to estimate the prevalence of EIMs in a Middle Eastern cohort of patients with IBD and correlate their occurrences.

Methods: We conducted a retrospective study involving all patients in the King Abdulaziz University (KAU) inflammatory bowel disease information system (IBDIS), between 2013 and 2018. Data on demographics, disease characteristics, and EIMs was analyzed using student t-testing and chi square testing. Logistic regression analysis was used to examine associations using STATA software.

Results: We reviewed the medical files of 284 patients, of which 158 (55.6%) were females. Mean age was 27.8 years. 146 (51.4%) patients had CD and 138 (48.6%) UC. The overall incidence risk of EIMs was 138 (41.6%), the most common was arthritis (88%). Pyoderma gangrenosum occurred in 21% of patients and was specific for CD (p=0.002), primary sclerosing cholangitis was more specific for UC (p=0.001). Certain EIMs appeared to occur together such as arthritis with PSC (p=0.001). Regression analysis identified disease type (in favor of UC; OR=0.50, p=0.03) and age at the time of diagnosis (OR=1.04, p=0.001) as significant predictors of EIMs.

Conclusion: Our results demonstrate that almost half IBD patients are at risk of EIMs and contrary to what has been reported, EIMS occur more commonly in UC compared to CD. A multidisciplinary assessment is recommended as a part of IBD management to improve overall health outcomes.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/15: CORRELATION OF TTG LEVEL WITH INTESTINAL HISTOPATHOLOGICAL CHANGES FOR CELIAC DISEASE AMONG ADULT SAUDI PATIENTS, FIRST EXPERIENCE FROM GULF REGION

Ibrahim Alharbi ¹, Abdelmoneim Sweid ¹, Memon Yousef ¹

Background: Celiac disease is chronic autoimmune intestinal disorder that affects genetically predisposed individuals who develop an immune reaction to gluten containing food. Worldwide, The prevalence of celiac disease (CD) approximately 1-2 %, and varies greatly. The prevalence of CD in Middle Eastern and North African regions was lower than other regions. However, with the improvement in diagnostic techniques, CD has been increasing in these regions, and become similar to that of North American and European countries. And in Saudi Arabia there are studies suggested that it maight be one of the highest in the whole world. Celiac disease is diagnosed by combination of serologic testing and related duodenal histopathologic fidnings. However, according to recent guidelines, a diagnosis can be made without a biopsy, especially in children. There is no enough studies, despite high prevelance and differences in genetic, race and cultures. Therefore, we examined the correlation between TTG and duodenal biopsy changes in our region as we are identical and different from others in culture, environment and habits and is the correlation same as different regions.

Methods: A retrospective cohort study at the Ministry of National Guard Health Affaires (NGHA) health care fascilities that are distributed throughout kingdom of Saudi Arabia from the 19^th of April 2015 till the 29^th of March 2018. All diagnosed celiac patients, whom ages 15 on ward, confirmed by improvement on GFD, not on GFD before endoscopy or serology test or both of them, and TTG IgA level was measured at same time or within 2-3 months of biopsy date. The exclusion criteria were; negative duodenal biopsy which is less than 2, subjects with negative biopsy and negative serology, subjects whom were on GFD before testing, and any patients known to have immunity diseases or illness cause mucosal changes. The TTG IgA blood levels measured in IU/ml divided into; negative, and positive (<20 IU/ml, ≥ 20 IU/ml). Whereas, intestinal biopsy findings were identified as Marsh classification groups.

Results: Around 500 celiac patients collected but only 134 celiac patients were included in the study. Median age of our sample 24 years old (16-37). Majority were female 99 (73%), males were 35 (26%). Histopathological investigation of intestinal biopsy were: Marsh 0 group was 16 cases (11.9%), Marsh 1 group was 8 cases (6%), Marsh 2 group was 4 cases (3%), Marsh 3a group was 32 cases (23.9%), Marsh 3b group was 64 cases (47.8%), and Marsh 3c group was 10 cases (7.5%). The TTG IgA antibody serology groups were: <20 IU/ml; 13 (9.7%), and ≥20 IU/ml; 121 (90.3%). Among all celiac patients who had negative biopsy (Marsh 0 group); 16 (100%) of them had positive TTG IgA antibody. However, patients with Marsh 1 group biopsy; 5 (62.5%) cases had negative TTIgA antibody compared to 3 (37.5%) cases were positive. Four cases (100%) with Marsh 2 group, all of them had positive TTIgA antibody. Though, in Marsh 3a group biopsy 3 (9.4%) cases had negative TTIgA antibody compared to 29 (90.6%) had positive TTIgA antibody. Furthermore, patients with Marsh 3b group biopsy; 5 (7.8%) had negative antibody and 59 (92.2%) had positive serology. All biopsies of Marsh 3c group; 10 (100 %) had positive TTIgA antibody. The prevalence of cases with high TTG IgA antibody (n=121) and negative intestinal biopsy (n=16) was 13.22%.

Conclusion: In perspective of high prevelance of CD in KSA, even more than western counteries, we can pretend that positive tTG antibody tests can be applied for the diagnosis of CD without biopsy, particularly in symptomatic patients along with high titer i.e. 5-10 times ULN. However, to validate it further, we need larger prospective studies where doudenal biopsies should be taken according to recommended protocol and should be be interpreted by experienced pathologist. Furthermore, biopsy is still needed in patients who do bot show clinical improvement on a gluten-free diet and in cases with mildly or modestly elevated IgA-Ttg.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/16: ENVIRONMENTAL EXPOSURES AND THE RISK OF INFLAMMATORY BOWEL DISEASE: A CASE CONTROL STUDY FROM SAUDI ARABIA

Wafaa Algethmi ¹, Cedric Baumann ², Wed Alnajjar ¹, Aaliah Sroji ¹, Majid Alsahafi ¹, Hani Jawa ^1,³, Yousef Qari ^1,³, Laurent Peyrin-Biroulet ², Omar Saadah ^3,⁴, Mahmoud Mosli ^1,³

Background: Environmental exposures play a key role in inflammatory bowel disease (IBD) pathogenesis. The incidence of IBD has increased in the Arabic Peninsula and disease phenotype in the Arabic population differs from that of Western countries. No previous studies have examined the association between environmental exposures and the risk of IBD in Saudi Arabia.

Patients and Methods: We performed a case-control study comparing Saudi individuals with confirmed IBD and healthy controls. All subjects completed a detailed questionnaire that included data on demographics, clinical characteristics, childhood exposures, socioeconomic exposures, and parent factors. Associations between risk factors and IBD were investigated through univariate and multivariate regression analysis.

Results: The analysis included 82 patients and 160 controls. Gender (male 45% vs. 15.6%, p = < 0.0001), age (> 25, 55.6 vs. 38.3%, p = 0.0115), and education level (> secondary education, 78.8% vs. 48.7%, p < 0.0001) differed between patients and controls. According to multiple logistic regression analysis, having a University/Master degree education level or a PhD degree reduced the risk of IBD by 10 fold (OR = 0.1, CI = 0.1 - 0.3), receiving 7 vaccines or more during childhood increased the risk of developing IBD by 9 fold (OR = 9.2, CI = 2.9 - 29.4) and maternal use of OCPs increased the risk by 11 fold (OR = 11.4, CI = 3.3 - 39.3).

Conclusions: IBD occurrence was independently associated with education level, number of childhood vaccination, and maternal use of OCPs in this population of IBD patients. This is the first study examining environmental exposures as risk factors for IBD in Saudi Arabia.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/17: PREVALENCE OF ASYMPTOMATIC GALL STONES AND KIDNEY STONES IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE

Abdulrahman Alzahrani ¹, Moaid Binsalman ¹, Majid Alsahafi ¹, Hani Jawa ¹, Yousef Qari ¹, Mahmoud Mosli ¹

Background: Inflammatory bowel disease (IBD) is a systemic inflammatory disorder that leads to inflammation in the bowel in addition to multiple extra-intestinal manifestations. Patients with IBD are at risk of developing gallstones and kidney stones due to altered bowel function. We aimed to estimate the prevalence of asymptomatic radiologically detected gallstones and kidney stones in a cohort of patients with IBD.

Patients and Methods: The King Abdulaziz University Hospital (KAUH) inflammatory bowel disease information system (IBDIS) registry was used to identify patients with IBD who underwent cross sectional imaging (CT or US) regardless of age. Clinical, laboratory, and radiological data were collected. The prevalence of radiologically detected stones found in the gall bladder or kidneys were considered the primary outcome of the study. Correlation between the presences of stones on imaging with clinical features was also assessed through logistic regression analysis. Odds ratios (OR) with 95% confidence intervals (95% CI) were generated.

Results: A total of 273 patients fulfilled study criteria. Mean age was 34 (±15.9 SD) and 52% were females. Sixty percent had Crohn’s disease (CD) and 33% had ulcerative colitis (UC). 44/273 (16%) and 9/273 (3.3%) had history of bowel resections and cholecystectomy, respectively. Based on cross sectional imaging, 24/273 (8.8%) patients were found to have gallstones and 15/273 (5.6%) patients had kidney stones. According to logistic regression, history of intestinal resection (OR=4.7, 95% CI = 1.8-12.5) was an independent predictor of gallstones but not kidney stones.

Conclusions: The prevalence of asymptomatic gallstones and kidney stones in patients with IBD remains low. History of intestinal resection is predictive of gallstones.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/18: ANTIMICROBIAL SCREENING AND ANTIULCEROGENIC EFFECTS OF LEPIDIUM SATIVUM EXTRACT ON HELICOBACTER PYLORI INDUCED GASTRIC ULCER IN A RAT MODEL

N A Salem ^1,^2,³, G S Ibrahim ^1,^2,⁴, M I Al Khalaf ^1,²

Background: Gastric ulcer caused by Helicobacter pylori is one of the most widespread diseases affecting the GI tract. The objective of the present study was to evaluate antimicrobial and antioxidant effect of Lepidium sativum (L.sativum) seeds methanolic extract and to correlate with antiulcer or gastroprotective potential of this extract using in vitro and in vivo models.

Methods: Methanolic extract of L.sativum seeds was separated and quantified for phenolic compounds using HPLC, antimicrobial activity of the extract was determined using Agar well diffusion method and its antioxidant potential was evaluated by the 2, 2-diphenyl-1-picrylhydrazyl radical scavenging method invitro. Furthermore, an in vivo rat model was assessed to explore the antiulcer, anti-inflammatory, antioxidant and anti-apoptotic effects of the extract against Helicobacter induced gastric ulcer.

Results: L. sativum extract exhibited significant antioxidant activity and potent antimicrobial activity against different pathogenic organisms in vitro. Moreover, treatment of ulcerated rats with L.sativum alleviated adverse effects of H. pylori induced gastric injury as demonstrated by reducing ulcer index and elevating % of ulcer inhibition. L.sativum extract halted gastric oxidative stress via inhibiting lipid peroxides and enhancing antioxidant markers Moreover, the extract suppressed gastric inflammation and apoptosis by decreasing, tumor necrosis alpha, interleukin 1 beta, monocytochemoattractant protein -1 and caspase 9. Histopathological investigation revealed that L. sativum treated rats showed amelioration of epithelial erosion, restoration of enterocytes and intact mucosal layer.

Conclusion: L.Sativum extract exhibited antimicrobial, antioxidant, antiulcerogenic, anti-inflammatory effects and notable cytoprotective activity against H.Pylori induced gastric ulcer.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/19: THE PROPHYLACTIC EFFICACY OF CARDAMOM (ELETTARIA CARDAMOMUM) EXTRACT AGAINST ASPIRIN-INDUCED GASTRIC ULCER IN A RAT MODEL

Amal H Hamza ^1,², Rasha H Hussein ^1,², Maha Alkhalf ¹

Background: Gastric ulcer is a common illness affecting millions of individuals In this study, the gastroprotective and therapeutic effects of cardamom extract and the main causal mechanisms were examined using aspirin-induced gastric ulcers.

Methods: Male albino rats were separated into healthy control and peptic ulcer-induced groups. The latter group was treated with cardamom extract before or after ulcer induction to investigate its protective and therapeutic effects. This group was also treated with Omeprazole. At the end of the experiment, the rats were sacrificed, and the gastric tissue was examined for ulcer index and score, pH and total acidity measurements. Moreover, we studied anti-inflammatory and antioxidant biomarkers.

Results: Cardamom treatment exerts an ameliorative effect, as shown by a decrease in the gastric ulcer index and score. In addition, the extract restores the free radical-scavenging enzymes and reduces inflammatory markers. Furthermore, pepsin and putrescine levels decreased significantly, while hydroxyproline levels increased in the groups treated with cardamom extract, either as a protective or therapeutic agent.

Conclusion: cardamom is therapeutically valuable for enhancing and hastening gastric ulcer remediation as it is capable of inhibiting aspiring-induced damage. The extract’s use resulted in more protective than therapeutic effects.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/20: PREDICTORS OF REFLUX ESOPHAGITIS AMONG PATIENTS UNDERGOING UPPER GI ENDOSCOPY

Fatma Salah ¹, Mohammed Hejazi ¹, Heba Mimish ¹, Emad Aljahdli ¹, Mahmoud Mosli ¹, Hani Jawa ¹, Yousef Qari ¹, Majid Alsahafi ¹

Background: Reflux esophagitis (RE) is present in about one third of patients with gastroesophageal reflux disease (GERD), some of which may not have typical GERD symptoms. The presence of RE is associated with the risk of developing peptic stricture and Barrett’s esophagus. In this study, we aim to determine the predictors of RE among Saudi patients undergoing esophagogastroduodenoscopy (EGD).

Methods: We retrospectively reviewed the endoscopy database at an academic tertiary care center. Consecutive adult patients who underwent EGD for any indication between 2015 and 2018 were included. Clinical and endoscopic data was collected including age, gender, body mass index, presence of RE and hiatal hernia. Multivariate regression analysis was used to identify predictors of RE.

Results: A total of 1075 patients were included. The mean age was 49.5 (±17.7) and 457 (42.5%) were male. Fifty one (4.7%) patients underwent EGD for GERD indication. RE was noted in 126 (11.7%) of all patients and 16 (31.3%) of patients with GERD indication. On multivariate analysis, only GERD indication and hiatal hernia were significantly associated with reflux esophagitis, (aOR= 2.87, 95% 1.4 - 5.5) and (aOR= 1.7, 95% 1.1 - 2.5) respectively.

Conclusion: RE is present in 13.2% of the Saudi population who undergo EGD. Symptomatic GERD and hiatal hernia are independents predictors for the presence of RE.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/21: THE RATE AND PREDICTORS OF IN-HOSPITAL MORTALITY AMONG CIRRHOTIC PATIENTS ADMITTED WITH SPONTANEOUS BACTERIAL PERITONITIS

Majid Alsahafi ¹, Hatim Khatib ¹, Alaa Bakheet ¹, Wedyan Aboznadah ¹, Raghad Alraddadi ¹, Sarah Nagadi ¹, Hind Fallatah ¹, Hisham Akbar ¹

Background: Spontaneous bacterial peritonitis (SBP) is a major cause for morbidity and mortality among patients with decompensated liver cirrhosis. The aim of this study is to determine the rate and predictors of in-hospital mortality among patients admitted with SBP.

Methods: We retrospectively reviewed the hospital records at an academic hospital for all cirrhotic patients admitted with SBP between 2008 and 2017. SBP was diagnosed when the polymorphonuclear leukocytes (PMN) count is >250. Clinical and laboratory data was collected. Multivariate regression analysis was used to determine predictors of mortality.

Results: A total of 102 patients admitted with SBP were identified. The mean age was 57.1 (± 15), and 67 (65.6%) were male. HCV was the most common cause for cirrhosis (44.1%), followed by NASH (17.6%) and HBV (14.7%). The mean albumin, INR and total bilirubin on admission were 20.7 g/L (±13.2), 1.8 (±0.8) and 91.4 umol/L (± 111) respectively. The mean creatinine on admission was 176.6 umol/L (±141). Thirty nine patients died during hospitalization, which results in a 38.2% in-hospital mortality. In multivariate analysis, only high INR (p=0.01) and older age (p=0.01) were associated with increased mortality.

Conclusions: SBP is associated with 38% in-hospital mortality. Elevated INR and older age are independently associated with increased mortality.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/22: EFFICACY OF QUADRUPLE THERAPY REGIMEN FOR HELICOBACTER PYLORI ERADICATION IN SAUDI ARABIA

Fahad Alsohaibani ¹, Mohammed Alquaiz ¹, Hamad Alashgar ¹, Musthafa Peedikayil ¹, Khalid Alkahtani ¹, Abdulrahman Alfadda ¹

Background: The efficacy of Helicobacter Pylori (h.pylori) eradication has been decreasing over the years due to the increased incidence of resistance to multiple antimicrobial therapies. The most effective treatment regimen for Saudi Arabian patients infected with h.pylori is still unknown. Objectives: To study the eradication rate after ten days of quadruple therapy (Pylera) for H pylori infection.

Methods: Patients found to have h.pylori infection (based on upper gastrointestinal endoscopy and rapid urease test (RUT) and/or histology and/or tissue culture were recruited. Eligible patients were given a course of quadruple therapy (Pylera). Each Pylera tablet contained bismuth subsalicylate 420 mg, metronidazole 375 mg, and tetracycline 375 mg. These medications were given 4 times daily for 10 days along with omeprazole 20 mg twice daily. Patients were considered cured from h.pylori if the urea breath test (UBT) was negative after 6 weeks of completion of the treatment.

Results: Ninety-two patients with H pylori infection were recruited. The mean age was 46.5 years and 58% were females. Naive patients were 70 (76%), and the remaining patients had H pylori treatment in the past; 5 (5.4%) of them had received sequential therapy, and 17 (18.4%) had triple therapy regimen in the past. Treatment compliance was 100% in 76 (87.4 %) patients. Five patients’ treatment compliance was 50% or less. Two patients were excluded from the study due to refusal to take the treatment or due to refractory vomiting. One patient could not tolerate the treatment due to severe vomiting. Ten patients did not show up for UBT. Finally, 79 patients’ post-treatment UBT results were available. The overall eradication rate on an intention-to-treat analysis was 69/92 (75%). The eradication rate as per protocol analysis was 87.3% (69/79). Neither patients’ treatment compliance (p value 0.63) nor previous treatment status (p value 0.65) influenced the eradication rate.

Conclusion: Our study showed that 87.3% of the patients who completed the research protocol were cured of H pylori infection.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/23: CLINICAL PRESENTATION, RESPONSE TO THERAPY AND PREGNANCY OUTCOME OF PATIENTS HOSPITALIZED WITH INTRAHEPATIC CHOLESTASIS OF PREGNANCY: A CASE SERIES

Sarah Nagadi ¹, Hind Fallatah ¹, Hisham Akbar ¹, Mahmoud Mosli ¹, Majid Alsahafi ¹

Background: Intrahepatic cholestasis of pregnancy (ICP) is a unique pregnancy related hepatic disorder that could lead to adverse fetal outcomes. While ICP has been well studied in the western world, there is limited local data. The aim of this study is evaluate the clinical features and pregnancy outcome of patients hospitalized with ICP.

Methods: We retrospectively reviewed the hospital records for patients admitted with ICP from 2013 to 2018. ICP was defined based on the standard criteria after exclusion of other liver diseases. Clinical data was collected including patients demographics, clinical and laboratory features, response to therapy and pregnancy outcomes. The Wilcoxon signed rank test was used to assess the response to therapy.

Results: A total of 17 patients were admitted with ICP. The mean age was 33 years. Four patients presented with ICP in their first pregnancy, while 13 patients had prior pregnancy. Among the 13 patients who had prior pregnancy, 4 (30.7%) had prior diagnosed ICP. The mean gestational age at presentation was 31 week (range 17 to 37). The mean presenting and peak ALT, AST, ALP, GGT and bilirubin were 245 U/L, 186 U/L, 228 U/L, 49 U/L, 10 umol/L; and 274 U/L, 221 U/L, 273 U/L, 61 U/L and 27 umol/L respectively. All patients received ursodeoxycholic acid at 13-15 mg/kg per day, while 7 (41.17%) and 5 (29.41%) received antihistamines and cholestyramine respectively. The mean ALT, AST after treatment were 126 U/L (p=0.007) and 74 U/L (p=0.03) respectively. The mean gestational age at delivery was 36 week, with 7 (41.14%) preterm births. No cases of intrauterine growth restriction or fetal death were associated with ICP.

Conclusion: We reported the clinical presentation and outcome for hospitalized patients with ICP. Ursodeoxycholic acid effectively improved liver enzymes and preterm labor was the most common pregnancy complication with no cases of fetal death.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/24: THE PREVALENCE OF BARRETT’S ESOPHAGUS AMONG PATIENTS UNDERGOING UPPER GI ENDOSCOPY: A RETROSPECTIVE ANALYSIS

Majid Alsahafi ¹, Fatma Salah ¹, Mohammed Hejazi ¹, Heba Mimish ¹, Emad Aljahdli ¹, Mahmoud Mosli ¹, Hani Jawa ¹, Yousef Qari ¹

Background: Barrett’s esophagus (BE) is a precursor condition for esophageal adenocarcinoma that develops in patients with gastroesophageal reflux disease (GERD). While GERD is common in the Saudi population, the prevalence of BE in the Saudi population is unknown. In this study, we aim to determine the prevalence of BE among patients undergoing esophagogastroduodenoscopy (EGD).

Methods: We retrospectively reviewed the endoscopy database at an academic tertiary care center. Consecutive adult patients who underwent EGD for any indication between 2015 and 2018 were included. Clinical and endoscopic data was collected including age, gender, body mass index and the presence of hiatal hernia. The prevalence of both endoscopically and histologically reported BE were determined. Multivariate regression analysis was used to identify factors associated with BE.

Results: A total of 1075 patients were included. The mean age was 49.5 (±17.7) and 457 (42.5%) were male. 51 (4.9%) patients underwent EGD for GERD indication and reflux esophagitis was noted in 126 (13.2%) patients. BE was reported endoscopically only in 12 (1.1%) patients and confirmed histologically only in 4 (0.37%). Among patients with endoscopically reported BE, the mean age was 43.9 (±17) year and 10 (83.3%) were male. Short segment BE was reported in 11 (91.6%) patients. Among the 4 patients with histologically confirmed BE, no dysplasia was detected. On multivariate regression analysis, male gender was the only factor significantly associated with BE (aOR 7.14, p=0.01).

Conclusion: In this endoscopic study, BE was reported in 1.1% and confirmed histologically in 0.37% of the Saudi population. Male gender was the only factor independently associated with BE.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/25: A PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIAL COMPARING THE EFFICACY OF POLYETHYLENE GLYCOL ALONE VERSUS POLYETHYLENE GLYCOL COMBINED WITH TOPICAL DILTIAZEM IN TREATING ANAL FISSURE IN CHILDREN

Abdullah Alshehri ¹, Rakan Barghouthi ¹, Saleh Albanyan ¹, Maria Alayed ¹, Hadeel Alsubaie ¹, Rawan Alhayyan ¹, Ayman Aljazaeri ¹

Background: Anal fissure (AF) is a relatively common condition affecting children and is usually treated with laxatives and/or topical agents. Topical sphincter relaxing agents including calcium channel blockers (CCB) has gained popularity as an effective treatment for AF among adults. We hypothesize that due to the superior efficacy of Polyethylene glycol (PEG) in treating constipation in children and consequently accelerating AF healing, adding topical adding topical CCB to the treatment might not be necessary.

Methods: Children ≤14 years with anal fissure presented to the pediatric surgery clinic between November 2014 to March 2016 were recruited, excluding those with previous illnesses affecting the rectum or perianal area. Randomization was performed to either PEG with placebo or PEG with DTZ. Study personnel, patients, and their families were blinded. Primary outcome was healing of the anal fissure documented by physical examination or the resolution symptoms. Secondary outcome was the presence of constipation symptoms or treatment complications at 12-week follow up.

Results: 48 patients were randomized: 24 in PEG + placebo group and 24 to PEG + DTZ. Both groups were similar in their baseline characteristics. Median age was 32 and 26.5 months in the placebo and DTZ groups respectively. At week 12, the majority of patients’ symptoms have improved with no statistically significant difference between both groups. Additionally, there was similar improvement in the degree of constipation in both groups.

Conclusion: PEG alone was associated with similar improvement in anal fissure symptoms in children compared to PEG and topical diltiazem combined.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/26: AWARENESS OF CRC AMONG INDIVIDUALS ATTENDING A TERTIARY ONCOLOGY CENTER IN THE WESTERN REGION OF KINGDOM OF SAUDI ARABIA

Abdullah Al Moshadq ¹, Abdulwahab Niazi ¹, Hosam Al Ghanmi ¹, Abulelah AhmadJey ¹, Saad Alqarni ¹, Adnan Al-Zanbagi ¹, Ishtiaq Ahmed ¹, Abdulaziz Tashkandi ¹, Mohammad Sharif ¹, Emad Tashkandi ^1,², Yaser Meeralam ¹

Background: Colorectal cancer (CRC) is the third most common cancer in the world. The Kingdom of Saudi Arabia (KSA) is a low-risk country for CRC; however, the incidence of CRC is increasing and ranks first among men and second among women. Aim: to assess the knowledge of CRC including its rick factors, symptoms and prognosis among healthy individuals attending King Abdullah Medical City, Makkah, a tertiary referral center for cancer.

Methodology: A cross-sectional questionnaire based observational study. In a face-to-face interview, consenting individuals filled in multiple-choice questions including demographics and level of education.

Results: A total of 358 participants completed the survey. 59% of respondents were postgraduates with 51% females. Majority (53%) were not aware of the screening age with more than one-third believing its done at start of symptoms. The awareness of risk factors was low with only 18% believing family history and young age at CRC were a risk. 47% were unaware of the symptoms of CRC. 86% believed that CRC could be cured and 26% believed incidence of CRC was high. Knowledge of colorectal cancer was significantly higher among male and healthcare practitioner. We did not find age to be significant predictor for knowledge related to colorectal cancer.

Conclusion: In this cohort, the awareness of CRC was low despite high level of education with inaccurate knowledge about symptoms, risk factors and screening. The study is limited due to the sample size and selected population.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/27: TOFACITINIB FOR THE TREATMENT OF ULCERATIVE COLITIS: UP TO 5.4 YEARS OF SAFETY DATA FROM GLOBAL CLINICAL TRIALS

William J Sandborn ¹, Julian Panés ¹, Remo Panaccione ², Geert R D’Haens ³, Bruce E Sands ⁴, Chinyu Su ⁵, Michele Moscariello ⁵, Thomas V Jones ⁵, Ronald D Pedersen ⁵, Nervin Lawendy ⁵, Gary Chan ⁵

Background: Tofacitinib is an oral, small molecule Janus kinase inhibitor approved for the treatment of ulcerative colitis (UC). Efficacy and safety of tofacitinib as induction/maintenance therapy were evaluated in Phase (P) 2/3 randomised, placebo-controlled studies,[1,2] and an ongoing, open-label, long-term extension (OLE) study.[3] We report updated tofacitinib safety analyses from the UC programme (exposure up to 5.4 years).

Methods: Patients receiving placebo, tofacitinib 5 or 10 mg twice daily (BID) were analysed as two cohorts: Maintenance (P3 maintenance, N=592) and Overall (all patients receiving tofacitinib 5 or 10 mg BID in P2/P3/OLE studies, N=1157; 2050.5 patient-years’ exposure; November 2017 datacut). Proportions and incidence rates (IRs; unique patients with events per 100 patient-years) were evaluated for adverse events (AEs) of special interest. Results from the December 2016 datacut are presented for context.

Results: Demographics and disease characteristics were generally similar among treatment groups across cohorts. For the Overall Cohort, most patients (N=956, 83%) received an average tofacitinib dose of 10 mg BID. IRs for AEs of special interest were similar to those in the previous datacut [Table 1].

Table 1.

Baseline demographics and disease characteristics, and incidence rates (unique patients with events per 100 patient-years) for adverse events of special interest in the tofacitinib ulcerative colitis programme, for each cohort


	Maintenance cohort						Tofacitinib all (n=1157)
	Placebo (n=198)		Tofacitinib 5 mg BID (n=198)		Tofacitinib 10 mg BID (n=196)		Overall cohort - December 2016 (induction + maintenance + OLE)		Overall cohort - November 2017 (induction + maintenance + OLE)
Age (years), mean (SD)	43.4 (14.0)		41.9 (13.7)		43.0 (14.4)		41.3 (13.9)		41.3 (13.9)
Female, %	41.4		48.0		43.9		41.3		41.3
Race, n (%)
White	155 (78.3)		164 (82.8)		153 (78.1)		927 (80.1)		927 (80.1)
Asian	26 (13.1)		23 (11.6)		25 (12.8)		144 (12.4)		144 (12.4)
Total Mayo score at baseline, mean (SD)	3.3 (1.8)		3.3 (1.8)		3.4 (1.8)		8.6 (2.0)		8.6 (2.0)
Disease duration (years), mean (SD)	8.8 (7.5)		8.3 (7.2)		8.7 (7.0)		8.2 (7.0)		8.2 (7.0)
Total patient-years of exposure	100.4		146.2		154.3		1612.8		2050.5
Treatment duration (days), median (range)	138 (14-382)		363.5 (22-420)		368 (1-399)		514 (1-1606)		609 (1-1961)
Patients with AEs, n (%)	149 (75.3)		143 (72.2)		156 (79.6)		950 (82.1)		969 (83.8)
Patients with SAEs, n (%)	13 (6.6)		10 (5.1)		11 (5.6)		169 (14.6)		189 (16.3)

	n (%)	IR (95% CI)	n (%)	IR (95% CI)	n (%)	IR (95% CI)	n (%)	IR (95% CI)	n (%)	IR (95% CI)

Death	0 (0.0)	0.0 (0.0-3.6)	0 (0.0)	0.0 (0.0-2.5)	0 (0.0)	0.0 (0.0-2.4)	4 (0.3)	0.2 (0.1-0.6)	5 (0.4)^a	0.2 (0.1-0.6)
Serious infection	2 (1.0)	1.9 (0.2-7.0)	2 (1.0)	1.4 (0.2-4.9)	1 (0.5)	0.6 (0.0-3.5)	33 (2.9)	2.0 (1.4-2.8)	39 (3.4)	1.9 (1.3-2.5)
Herpes zoster	1 (0.5)	1.0 (0.0-5.4)	3 (1.5)	2.1 (0.4-6.0)	10 (5.1)	6.6 (3.2-12.2)	65 (5.6)	4.1 (3.1-5.2)	76 (6.6)	3.8 (3.0-4.7)
Opportunistic infection^b	1 (0.5)	1.0 (0.0-5.4)	2 (1.0)	1.4 (0.2-4.9)	4 (2.0)	2.6 (0.7-6.7)	21 (1.9)	1.3 (0.8-2.0)	25 (2.2)	1.2 (0.8-1.8)
Nonherpes-zoster opportunistic infection^b	0 (0.0)	0.0 (0.0-3.6)	0 (0.0)	0.0 (0.0-2.5)	0 (0.0)	0.0 (0.0-2.4)	4 (0.4)	0.2 (0.1-0.6)	4 (0.4)	0.2 (0.1-0.5)
Malignancy (excluding NMSC)^b,c	1 (0.5)	1.0 (0.0-5.4)	0 (0.0)	0.0 (0.0-2.5)	0 (0.0)	0.0 (0.0-2.4)	8 (0.7)	0.5 (0.2-1.0)	13 (1.2)	0.6 (0.3-1.1)
NMSC^b	1 (0.5)	1.0 (0.0-5.4)	0 (0.0)	0.0 (0.0-2.5)	3 (1.5)	1.9 (0.4-5.6)	11 (1.0)	0.7 (0.3-1.2)	16 (1.4)	0.8 (0.4-1.3)
MACE^b	0 (0.0)	0.0 (0.0-3.6)	1 (0.5)	0.7 (0.0-3.8)	1 (0.5)	0.6 (0.0-3.5)	4 (0.4)	0.2 (0.1-0.6)	6 (0.5)	0.3 (0.1-0.6)
Gastrointestinal perforation^b,d	1 (0.5)	1.0 (0.0-5.4)	0 (0.0)	0.0 (0.0-2.5)	0 (0.0)	0.0 (0.0-2.4)	3 (0.3)	0.2 (0.0-0.5)	3 (0.3)	0.1 (0.0-0.4)

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^aCauses of death were one case each of aortic dissection, pulmonary embolism, hepatic angiosarcoma, acute myeloid leukaemia and malignant melanoma; ^bAdjudicated by independent adjudication committees. Percentage was calculated based on the number of patients in studies in which adjudication was performed; ^cOne case of breast cancer in the maintenance cohort (placebo arm), and, in the overall cohort, one case each of cervical cancer, hepatic angiosarcoma, cholangiocarcinoma with metastases to peritoneum, leiomyosarcoma, Epstein-Barr-virus-associated lymphoma, malignant melanoma, renal cell carcinoma, lung cancer, invasive ductal breast carcinoma, adenocarcinoma of the colon with metastases to the liver, essential thrombocythaemia, acute myeloid leukaemia and adenocarcinoma of the colon; ^dGastrointestinal perforation excludes fistulae, pilonidal cysts and abscesses below peritoneal reflection. Data are from phase 3 induction studies (OCTAVE Induction 1 and 2; NCT01465763 and NCT01458951, respectively), the phase 3 maintenance study (OCTAVE Sustain; NCT01458574) and the OLE study (OCTAVE Open; NCT01470612). Adjudicated data do not include data from the Phase 2 Study (A3921063; NCT00787202). AEs: Adverse events, BID: Twice daily, CI: Confidence interval, IR: Incidence rate, MACE: Major adverse cardiovascular event, N: Number of patients in the treatment group, n: Number of unique patients with a particular AE, NMSC: Nonmelanoma skin cancer, OLE: Open-label, long-term extension, SAEs: Serious AEs, SD: Standard deviation, CI: Confidence interval

Conclusion: The safety profile of tofacitinib in patients with UC was similar to that previously reported in rheumatoid arthritis and, excepting the higher HZ IR, similar to biologic therapies for UC. IRs for AEs of special interest did not increase with longer exposure. A dose-dependent risk of herpes zoster was observed.

REFERENCES

1.Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, et al. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012;367:616–24. doi: 10.1056/NEJMoa1112168. [DOI] [PubMed] [Google Scholar]
2.Sandborn WJ, Su C, Sands BE, D’Haens GR, Vermeire S, Schreiber S, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376:1723–36. doi: 10.1056/NEJMoa1606910. [DOI] [PubMed] [Google Scholar]
3.Lichtenstein, et al. Am J Gastroenterol. 2017;112 Abstract714. [Google Scholar]

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/28: EFFICACY OF TOFACITINIB FOR THE TREATMENT OF MODERATE TO SEVERE ULCERATIVE COLITIS ACCORDING TO THE PRESENCE OF EXTRAINTESTINAL MANIFESTATIONS: DATA FROM THE OCTAVE INDUCTION STUDIES

Flavio Steinwurz ¹, Paulo Gustavo Kotze ¹, Carlos Francisconi ², Cyrla Zaltman ³, Marcia Pinheiro ⁴, Leonardo Salese ⁵, Haiying Zhang ⁵, Ena Singh ⁵, Dario Ponce de Leon ⁶

Background: Extraintestinal manifestations (EIM) occur in up to 40% of patients with inflammatory bowel disease,[1] affecting the joints, skin, eyes, vasculature and hepatobiliary tract. Tofacitinib is an oral, small molecule Janus kinase inhibitor approved for the treatment of ulcerative colitis (UC). We describe tofacitinib induction efficacy for patients with baseline EIM.

Methods: Pooled data from two 8-week, Phase 3 studies[2] (OCTAVE Induction 1&2; NCT01465763, NCT01458951) are presented. Patients received placebo or tofacitinib 10 mg twice daily. We evaluated Week 8 remission (primary endpoint) and mucosal healing rates, stratified by presence of prior/active investigator-determined EIM at baseline. Treatment differences and 95% confidence intervals were calculated using normal approximation; p values were based on chi-square test by EIM (Yes/No) at baseline.

Results: In total, 307/1135 patients (27.0%) had prior/active baseline EIM, of whom 67.1% had peripheral arthritis, 25.7% oral ulcer/stomatitis, 13.0% erythema nodosum, 9.8% thromboembolic disorder, 6.5% sacroiliitis, and 6.5% uveitis. The EIM group was older, had a greater proportion of females, fewer Asian patients and longer mean disease duration, vs the no-EIM group. At Week 8, remission and mucosal healing rates were significantly higher with tofacitinib 10 mg twice daily, compared with placebo, in both the EIM and no-EIM groups [all p<0.05; Table 1].

Table 1.

Baseline demographics and disease characteristics of patients with or without extraintestinal manifestation at baseline, and efficacy at week 8

Baseline demographics and disease characteristics	EIM at baseline (n=307)		No EIM at baseline (N=828)
Age (years), mean (SD)	43.5 (13.0)		40.4 (14.2)
Female, n (%)	164 (53.4)		307 (37.1)
Race, n (%)
White	260 (84.7)		649 (78.4)
Black	2 (0.7)		7 (0.8)
Asian	23 (7.5)		118 (14.3)
Other/unspecified	22 (7.2)		54 (6.5)
BMI, mean (SD)	25.7 (5.4)		24.5 (4.7)
Duration of UC (years), mean (SD)	9.2 (7.8)		7.7 (6.6)
Total Mayo score, mean (SD)	9.1 (1.4)		9.0 (1.4)
Prior treatment, n (%)
TNFi	191 (62.2)		426 (51.4)
Immunosuppressants	246 (80.1)		594 (71.7)
Oral corticosteroids	279 (90.9)		746 (90.1)

Efficacy at week 8	Tofacitinib 10 mg BID (N1=249)	Placebo (N1=58)	Tofacitinib 10 mg BID (N1=653)	Placebo (N1=175)

Remissiona, n (%)	44 (17.7)*	2 (3.4)	114 (17.5)**	12 (6.9)
Difference from placebo, % (95% CI)	14.2 (7.6-20.9)		10.6 (5.9-15.3)
Mucosal healing^b, n (%)	75 (30.1)*	8 (13.8)	194 (29.7)***	24 (13.7)
Difference from placebo, % (95% CI)	16.3 (5.8-26.9)		16.0 (9.8-22.2)

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*P<0.05; **P<0.001; ***P<0.0001 versus placebo, based on Chi-square test by subgroups of EIM (yes/no) at baseline. Treatment differences and 95% CI were calculated using normal approximation; ^aPrimary endpoint; defined as a total Mayo score of ≤2 with no individual subscore >1, and a rectal bleeding subscore of 0; ^bDefined as a Mayo endoscopic subscore of ≤1.

BID: Twice daily; BMI: Body mass index; CI: Confidence interval; EIM: Extraintestinal manifestation; N: Number of patients in EIM and no-EIM subgroups; n: Number of patients with each characteristic/endpoint; N1: Number of patients in a treatment group; SD: Standard deviation; TNFi: Tumour necrosis factor inhibitor; UC: Ulcerative colitis; CI: Confidence interval

Conclusion: After 8 weeks of tofacitinib induction therapy, improvements in UC symptoms were similar regardless of patients’ EIM status at baseline, and consistent with the overall study population.[2]

REFERENCES

1.Levine JS, Burakoff R. Extraintestinal manifestations of inflammatory bowel disease. Gastroenterol Hepatol (N Y) 2011;7:235–41. [PMC free article] [PubMed] [Google Scholar]
2.Sandborn WJ, Su C, Sands BE, D’Haens GR, Vermeire S, Schreiber S, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376:1723–36. doi: 10.1056/NEJMoa1606910. [DOI] [PubMed] [Google Scholar]

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/29: EFFICACY AND SAFETY OF DOSE ESCALATION TO TOFACITINIB 10 MG TWICE DAILY FOR PATIENTS WITH ULCERATIVE COLITIS FOLLOWING LOSS OF RESPONSE ON TOFACITINIB 5 MG TWICE DAILY MAINTENANCE THERAPY: RESULTS FROM OCTAVE OPEN

Bruce E ¹, Sands ¹, Alan C Moss ¹, Alessandro Armuzzi ², John K Marshall ³, James O Lindsay ⁴, William J Sandborn ⁵, Silvio Danese ⁶, Konstantinos Tsilkos ⁷, Nervin Lawendy ⁸, Haiying Zhang ⁸, Gary Chan ⁸, Daniel W Krichbaum ⁷, Chinyu Su ⁸

Background: Tofacitinib is an oral, small molecule Janus kinase inhibitor approved for the treatment of ulcerative colitis (UC). We evaluated the efficacy and safety of tofacitinib dose escalation in patients with UC from an ongoing, open-label, long-term extension (OLE) study (OCTAVE Open, NCT01470612; data cuts: July 2016 [efficacy], December 2016 [safety]).

Methods: OCTAVE included induction (OCTAVE Induction 1&2), maintenance (OCTAVE Sustain)[1] and OLE studies. The OLE study included induction non-responders and patients who completed or experienced treatment failure (TF) in maintenance. We analysed the OLE subpopulation who achieved clinical response after tofacitinib 10 mg twice daily (BID) 8week induction therapy, received tofacitinib 5 mg BID in maintenance, experienced TF between Weeks 8–52 and were escalated to tofacitinib 10 mg BID in OLE. Clinical response, mucosal healing and remission at Month (M) 2 and M12 using nonresponder imputation – and safety throughout the study – were evaluated.

Results: The dose-escalation subpopulation included 58/914 OLE patients. Efficacy endpoints at M2 and M12 in the OLE dose-escalation subpopulation are presented. The safety of tofacitinib 10 mg BID was generally consistent with the overall study population[2] [Table 1].

Table 1.

Summary of efficacy and safety in the OCTAVE open tofacitinib dose-escalation subpopulation

Efficacy, n/N (%)	Tofacitinib dose-escalation subpopulationa (n=58)^b
Clinical response^c
Baseline	3/58 (5.2)
M2	34/58 (58.6)
M12	33/48 (68.8)
Mucosal healing^d
Baseline	3/58 (5.2)
M2	24/58 (41.4)
M12	29/48 (60.4)
Remissione
Baseline	0/58 (0.0)
M2	20/58 (34.5)
M12	25/48 (52.1)

Safety, IR (95% CI)	n=57^b

Serious adverse event	6.8 (2.2, 15.8)
Herpes zoster	8.7 (3.2, 18.9)^f
Serious infection event	1.3 (0.0, 7.5)
Herpes zoster serious adverse event	0.0 (0.0, 4.9)
Opportunistic infection^g	0.0 (0.0, 4.9)
Malignancy (excluding NMSC)^g	1.3 (0.0, 7.5)^h
NMSC^g	1.4 (0.0, 7.5)ⁱ
Major adverse cardiovascular events^g	0.0 (0.0, 4.9)
Gastrointestinal perforation^g	0.0 (0.0, 4.9)
Death	0.0 (0.0, 4.9)

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Data are from Phase 3 induction studies (OCTAVE Induction 1 and 2; NCT01465763 and NCT01458951, respectively), the Phase 3 maintenance study (OCTAVE Sustain; NCT01458574) and the OLE study (OCTAVE Open; NCT01470612). Efficacy data are subpopulations of the full analysis set, non-responder imputation, based on local read of endoscopy, reported up to the July 2016 data cut-off. Patients were treated as non-responders after the time of discontinuation up to the visit they would have reached if they had stayed in the study. No imputation for missing data was applied for ongoing patients. Safety data are reported up to the December 2016 data cut-off. ^aThe dose escalation subpopulation comprised patients who had clinical response at week 8 with tofacitinib 10 mg BID in OCTAVE Induction 1 or 2, and subsequent treatment failure with tofacitinib 5 mg BID during OCTAVE Sustain. Treatment failure was defined as an increase of ≥3 points from baseline total Mayo score, plus an increase in rectal bleeding and endoscopic subscores of ≥1 point, and an absolute endoscopic subscore of ≥2 after ≥8 weeks. Per protocol, these patients received tofacitinib 10 mg BID in OCTAVE Open, ^bTwo patients who received tofacitinib 5 mg BID in OCTAVE Open are included in the efficacy analyses; the safety analyses excluded these two patients, but included one patient added since the July 2016 data cut-off, ^cClinical response was defined as a decrease from induction study baseline total Mayo score of ≥3 points and ≥30%, plus a decrease in rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of 0 or 1, ^dDefined as a Mayo endoscopic subscore of ≤1, ^eDefined as a total Mayo score of ≤2 with no individual subscore >1, and a rectal bleeding subscore of 0, ^fAll herpes zoster cases were limited to cutaneous involvement over one or two adjacent dermatomes; none resulted in permanent tofacitinib discontinuation, and four of the six cases had resolved at the time of reporting, gPer adjudication, ^hCervical cancer, (n=1), ⁱSquamous cell carcinoma, (n=1) BID, twice daily; CI, confidence interval; IR, incidence rate (unique patients with events per 100 patient-years). M: Month; N: number of evaluable patients; n: Number of patients with response in the given category; NMSC: Nonmelanoma skin cancer; OLE: Open-label, long-term extension; CI: Confidence interval

Conclusion: In patients losing tofacitinib 10 mg BID induction clinical response while on 5 mg BID maintenance therapy, dose escalation back to 10 mg BID recaptured clinical response for most by M2, and was well-tolerated with no new safety risk. Interpretation of adverse events was limited due to the small sample size.

REFERENCES

1.Sandborn WJ, Su C, Sands BE, D’Haens GR, Vermeire S, Schreiber S, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376:1723–36. doi: 10.1056/NEJMoa1606910. [DOI] [PubMed] [Google Scholar]
2.Lichtenstein, et al. Am J Gastroenterol. 2017 112:Abstract 714. [Google Scholar]

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/30: HEMORRHAGIC BRAIN METASTASIS AS THE INITIAL MANIFESTATION OF ESOPHAGEAL ADENOCARCINOMA

Hussein Algahtani ¹, Bader Shirah ¹, Yehya Seddeq ¹, Hatim Al-Maghraby ²

Esophageal carcinoma metastasis to the brain is very rare with less than 300 cases published worldwide. The reported incidence rates of esophageal carcinoma metastases to the brain range from 0.3% to 13%. It is associated with a worse prognosis than brain metastases from other solid tumors. The most common form of metastasis is cystic lesions while hemorrhagic metastasis represents a rare subset of an infrequent entity. It is extremely rare for esophageal carcinoma to present as an isolated brain metastasis with only three cases reported worldwide. These cases were misdiagnosed as meningitis, a pituitary tumor, and glioma. This paper reports the first case of hemorrhagic brain metastasis as the initial and only manifestation of esophageal adenocarcinoma worldwide. Although extensive work up to search for malignancy is a routine procedure in patients with metastatic brain disease, upper gastrointestinal endoscopy, which is rarely done as part of the work up should be included. Esophageal cancer continues to be challenging to manage with very limited therapeutic options. To date, the clinical outcome after treatment is unsatisfactory, and prognosis is poor. Further research is required to identify better treatment approaches and improve the survival of patients. This paper is an urgent call for action to design chemotherapeutic agents that target tumor cells in the blood and different body organs and has the ability to cross the blood-brain barrier with an acceptable side effect profile. This is mainly because metastatic brain disease has become more common in young age group.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/31: PREVALENCE AND CHARACTERISTICS OF NON-ALCOHOLIC FATTY LIVER DISEASE AMONG PATIENTS WITH CHRONIC LIVER DISEASES IN SAUDI ARABIA

Hind Fallatah ¹, Ammar Aldabbagh ¹, Mohammad Hejazi ¹, Sulaiman Hanbazazah ¹, Ali Hussein ¹

Background: None alcoholic fatty liver disease (NAFLD) is increasingly recognized as a cause for chronic liver disease (CLD) in different countries. NAFLD is the commonest cause for abnormal liver enzymes in Eastern and western countries. NAFLD is a disease that is related to metabolic syndromes, obesity and diabetes (DM). Obesity as a main risk factor for metabolic syndrome is increasingly recognized among Saudis and the Middle Eastern population as the highest prevalence all over the world is reported in this countries (25-30% of the population). On the other hand; the prevalence of type 2 DM is progressively increasing to alarming figures among Saudi population. The prevalence of NAFLD in Saudi Arabia was reported as 16.6% while another study among liver donors reported that 8% of donors had steatosis and 24.9% had either obesity or DM; resulting in donor rejection. Moreover, NAFLD prevalence among Saudi diabetic patients was reported as high as 55 %. Yet, the prevalence of NAFLD among patients with CLD in Saudi Arabia is not known. We conducted this work aiming to study the prevalence of NAFLD among patients with CLD.

Methods: A retrospective, chart review study that include all patient who had confirmed diagnosis of CLD and those who were diagnosed with NAFLD. All patient who fulfill inclusion criteria and presented to King Abdulaziz University Hospital, a large tertiary and academic center in Jeddah, Saudi Arabia was included in the study. The study duration was 3 years; from April 2015 to April 2018. All included patient underwent an assessment of liver steatosis and fibrosis using the transient electrography (fibroscan) during the study period.

Results: A total number of 494 patients with CLD were included in the study; NAFLD was diagnosed in 111 (22.5%) patients, the number and percentage of the patients with other causes of CLD is summarized in Table 1. The age of NAFLD patients ranges from 22-86 and they their mean age was significantly older compared to non-NAFLD patients. On the other hand, the NAFLD group showed significantly higher number and percentage of DM, HTN, hyperlipidemia, fatty liver and Cirrhosis on ultrasound examination. Table 2 summarizing demographic and clinical data of both groups. NAFLD patients had significantly higher serum ALT (mean 61.84 in NAFLD and 50.23 in non-NAFLD; P <0.001) and higher CAP (mean 297.83 vs 238.41; P<0.001) compared to none NAFLD patients. It was also noted that patient with cirrhosis detected on US examination had lower ALT level (P = <.001). There were no significant difference between two groups in BMI (30.62 vs 29.52), Hemoglobin level (13.33 vs 12.79), platelets count (257.65 vs 255.67), ALT (61.84 vs 50.23), albumin (35.60 vs 34.40), INR (1.05 vs 1.10), Bilirubin (14.15 vs 16.45), GGT (85.97 vs 80.91) and stiffness score –KPA- (12.09 vs 10.35). NAFLD patients showed mean HbA1C of 6.85 (CI 5-13, SD 1.748). The mean level for LDL, HDL, TG, FBS was 2.91, 1.18, 1.70, 7.16, respectively. Patients with NAFLD tend to have more severe fibrosis – as detected by fibroscan - compared to non-NAFLD patients; but the percentage was not statistically different (P=.31). The level of fibrosis in both groups was summarized in Table 3. On linear multi-regression analysis; both age and platelets count showed significant relation to the presence of features of cirrhosis on abdominal ultrasound, other factors such as age, gender, BMI, hemoglobin, ALT, INR, bilirubin, GGT, albumin and KPA score showed no significant relation.

Table 1.

Distribution of patients among causes of chronic liver disease

Diagnosis	Number of patients (%)
NAFLD	111 (22.5)
CHB	166 (33.6)
CHC	153 (31.0)
AIH	30 (6.1)
Methotrexate	19 (3.8)
Congenital cholestasis	1 (0.2)
Overlap syndrome	4 (0.8)
PBC	3 (0.6)
CHB + CHC	6 (1.2)
DILI induced AIH	1 (0.2)
Total	494 (100.0)

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NAFLD: Non-alcoholic fatty liver disease, CHB: Chronic hepatitis B, AIH: Autoimmune hepatitis, CHC: Chronic hepatitis C, PBC: Primary biliary cholangitis, DILI: Drug-induced liver injury

Table 2.

Demographic and clinical data of chronic liver disease patients

Variable	NAFLD n and %	None NAFLD\n and %	P
Nationality
Saudi	74	255	0.081
Non-Saudi	37	157
Sex
Male	51	172	0.465
Female	60	211
Age (years)	53.65	48.07	<0.001
DM	54 (48.6)	77 (20.1)	<0.001
HTN	46 (41.4)	65 (17)	<0.001
Fatty liver on ultrasound	64	16	<0.001
Hyperlipidemia	29 (26.1)	27 (7)	<0.001
Cirrhosis on ultrasound	18 (16.2)	14 (3.7)	<0.001

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DM: Diabetes mellitus, HTN: Hypertension, NAFLD: Non-alcoholic fatty liver disease

Table 3.

Level of fibrosis (F score) on fibroscan in chronic liver disease patients

	Number of patients		Total

	None NAFLD	NAFLD
F score
0	160	34	194
1	73	31	104
2	37	10	47
3	27	10	37
4	86	26	112
Total	383	111	494

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NAFLD: Non-alcoholic fatty liver disease

Conclusion: NAFLD incidence and prevalence is high and increasing in Saudi Arabia, this trend increases the burden of the disease on general health of population and in particular among CLD patients. In our study; NAFLD was diagnosed in 22.5% of CLD patients, and it was significantly associated with DM, HTN and dyslipidemia. Patients with NAFLD have high ALT and CAP score among CLD patients, and tend to have more fibrosis as detected by fibroscan.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/32: ERCP IN SITUS INVERSUS

Abbas Zagnoon ¹, Saad Almutairi ¹

Case Presentation: A 50 year-old female admitted with acute epigastric and left upper quadrant pain. She is known to have situs inversus, and a cholecystectomy. Her examination revealed mild epigastric tenderness. Her investigations: amylase: 1694 U/L, total bilirubin: 70.8 umol/L, direct bilirubin: 57. 6, ALT: 482, AST: 411, ALP: 204. Abdominal US showed bile duct dilatation with multiple distal CBD stones. She underwent an ERCP under general anesthesia with endotracheal intubation in a supine position with the endoscopist on her left side. The duodenoscope was introduced into the stomach; then to the duodenum. Once into the duodenum, the scope advanced and rotated anticlockwise with tip deflection, where it was possible to see the prominent papilla of Vater. The orifice was oriented caudally making it difficult to gain deep cannulation of the CBD. The prominent papilla made it easy to perform a precut needle-knife and gain deep access into the CBD then exchanged to sphinctrotome, and the sphinctrotomy was extended. Contrast was injected revealing filling defect in the distal CBD, with proximal ductal dilatation. A stone was extracted using a balloon extraction catheter. Balloon sweep of the bile duct confirmed clearance of the bile duct. No complication occurred.

Conclusion: ERCP in situs inversus is challenging. Several reports suggested different techniques. In our case, the patient was in supine position, and the endoscopist maintained usual position. The endoscope could reach the papilla without difficulty by the pushing method, together with the usual stretching method.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/33: ACCEPTANCE RATE FOR SCREENING COLONSCOPY IN AVERGE RISK SAUDI PATIENTS INVOVED IN SCREENING PROGRAM WITH POSITIVE FECAL OCCULT BLOOD, PRELIMINARY REPORT

A M Alakwaa ¹, A M Alshoaibi ¹, A K Almulla ¹, W R Alsubaiee ¹, F R Alanazi ¹, M A Aljaafari ¹

Background: Colorectal cancer screening is faced with many barriers. Patients refusal is a major barrier. Some patients reject the idea of colonoscopy after involvement in FOBT screening program. Exploration of this issue is required. Aims: To estimate the acceptance rate for screening colonoscopy post having positive FOBT and determine the refusal rate and reasons.

Methods: A retrospective review of electronic records for patients with positive FOBT screening referred to gastroenterology clinic for perusing colonoscopy. The reason for the referral, benefit of colonoscopy, procedure and complications were fully explained to the patients during the visit. Those who rejected colonoscopy given follow up visit. Demographic data, comorbidities, and reasons for refusal were recorded and entered in SPSS 20.

Results: Total of 156 referred, mean age 61 yrs (50 – 86 yrs). Male represented 63.5%. Comorbidities: DM, HTN, heart disease, chronic kidney disease, dyslipidemia were 62%, 62%, 12.5 %, 5.8%, 83%, respectively. Obesity and smoking were 61.5%, and 12%. Family history was present in only 1.2%. Colonoscopy was accepted by 121 (77.6%) and refused by 35 (22.4%). Causes of refusal were think about it 2.4%, need female endoscopist 2.4%. Afraid of pain, afraid of complications, doesn’t believe in the test each in 0.6 %. Doesn’t want to know about result 1.2%. Causes of refusal were not clear from the record in 22 (14%). No correlation between age, gender and refusal rate.

Conclusion: In spite of initial agreement for involvement in colorectal screening, large number of patients refused to undergo screening colonoscopy. Rejection reasons were not clearly explored in this sample. Prospective well-designed study should be conducted in order know the reasons and set proper intervention.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/34: EFFICACY OF DAA’S IN THE TREATMENT OF CHRONIC HCV: REAL WORLD DATA FROM THE PRIVATE HEALTH CARE SECTOR OF THE KINGDOM OF SAUDI ARABIA

Almoutaz H Hashim ¹, Emad Aldin M Albaba ¹, Fadia B Al Mahdi ², Ayman F Alsulaimani ³, Asmaa M Almahmoud ³, Ahmed I Nabil ³, Mahmoud H Mosli ⁴

Background: The hepatitis C virus (HCV) is a major global health problem that requires widespread active interventions for its prevention and control. The Middle East and North Africa (MENA) region has the highest prevalence of HCV worldwide. The prevalence of HCV in Saudi Arabia is uncertain because no recent studies have been conducted. The use of direct acting antiviral agents (DAAs) to treat chronic hepatitis C (HCV) has resulted in a significant increase in the rates of SVR (90%-95%) as compared with the treatment of Peg-interferon/Ribavirin. In this study, we aim to evaluate the effectiveness of DAA’s for HCV infected patients in the Kingdom of Saudi Arabia (KSA).

Patients and Methods: This is a retrospective cohort study of patients treated with DAA-based regimens for chronic HCV in the private health care sector hospitals of KSA between April 2015 and December 2017. Eligible patients were identified using an electronic database of one major health insurance company. Data regarding: presence or absence of liver cirrhosis, virus genotype, quantitative HCV RNA test, fibrosis stage and history of liver disease were included. The primary endpoint of the study was the overall cure rate, defined as the number of patients achieving sustained viral response (SVR) rate at least 12 weeks following the end of treatment, divided by the total number of patients included in the study.

Results: A total of 262 patients who were seen by gastroenterologists/ hepatologists in primary health care provider clinics were included in the study. Adult Patients were enrolled, of which 114 (44%) were females and 148 (56%) were males. 105 of the patients (40%) were cirrhotic. 157 patients were treatment-Naïve patients (60%), 84 patients were INF-experienced, and 20 patients had previously received new DAA’s but failed to achieve SVR. The major genotype detected was genotype 4 (79%). The majority of patients received Ledipasvir-sofosbuvir +/- RBV (57%) with SVR rate of approximately 97%.

Conclusions: Our local real world data indicates an overall HCV cure rate of 97% following treatment with DAA’s when prescribed in the private sector. This estimate is acquiescence with previously reported global cure rates.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/35: PREVALENCE AND CHARACTERISTICS OF LIVER DISEASE IN PREGNANCY IN SAUDI ARABIA, A TERTIARY CENTER EXPERIENCE

Hind Fallatah ¹, Ammar Aldabbagh ¹, Heba Mimish ¹, Abdullah Khaleel ¹, Ziad Traboulsi ¹, Abdullah Azab ¹, Mohammad Bukhary ¹, Hamdan Alguydi ¹

Background: Liver disease in pregnancy can be divided into non-pregnancy related disease and liver disease unique to pregnancy. Liver disease unique to pregnancy is etiologically related to gestation or its complications and these include hyperemesis gravidarum, intrahepatic cholestasis of pregnancy, eclampsia, pre-eclampsia, HELLP (hemolysis, elevated liver enzymes with low platelets) syndrome and acute fatty liver of pregnancy. Management of liver disease in pregnancy requires teamwork between obstetricians and gastroenterologists/hepatologists and this usually involves early delivery of the fetus and supportive care. In this study we focused on estimating the disease burden, characteristic and prevalence attributable to Liver disease of pregnancy in a tertiary center in KSA and to determine the magnitude and trends of these diseases as well as maternal and neonatal complications.

Methods: We conducted a retrospective descriptive record review of patients diagnosed with and/or referred to Hepatology service during the time period from January 1st 2017 to December 31th 2017. The patients included were fulfilling the criteria of diagnosis of any liver diseases unique to pregnancy. We excluded any patient not fulfilling the criteria or with pre-existing chronic liver disease, viral hepatitis or any causes of acute liver injury.

Results: Total number of patients was 112, The mean age was 29.8 Years (15-45 years). Patients with Hyperemesis Gravidarum (HG) were of younger age group compared with those with eclampsia and preeclampsia, patients with preeclampsia and eclampsia were significantly older than those with HG but there was no difference in the age of patients with eclampsia and preeclampsia compared to HELLP syndrome patients. Similarly the gestational week at presentation and the week of delivery were significantly higher for Preeclampsia, eclampsia and HELLP patients compared to HG. Table 1 summarized the maternal complications in relation to age. 48 patients (42.9%) were primigravida and 64 patients (57.1) were multigravida at the time of diagnosis. 18 patients (16.1%) presented at first trimester, while others presented at second and third trimester 9 and 83 (8% and 74.1%) respectively. There was no difference in the rate of occurrence of different pregnancy related liver disease between primigravida and multigravida mothers. P=.64. In regard to patients’ blood pressure (BP), the mean BP was 179/80. There was a significance difference in the mean BP at admission between patients with HG and HEELP (Means 91.68, SD1.74) and (145.83, SD 21) respectively (P=.033). Similarly the mean BP at admission was significantly higher in the Preeclampsia patients compared to HG mean (SD 132.54, 15.55 respectively) and P<.001. There was no significant difference in the mean BP at admission between Eclampsia and HELLP patients and the mean BP at admission between the Eclampsia and the preeclampsia group. It was also noted that 14 (12.5%) patients had ICU admission. Only 1 (0.9%) patient had ascites, 3 (2.7%) patients lost consciousness and 2 (1.8%) patients needed dialysis. Moreover 9 (8%) of patients had serum LDH >600 during admission and % (4.5%) had proteinuria >3.5. Regarding the mode of delivery and the termination of pregnancy, there were 39 patient who underwent spontaneous vaginal delivery (SVD), however 73 patients (65.2%) patients had termination of pregnancy; 71 of them (63.4%) was delivered by cesarean section (CS) and 2 (1.78%) by assisted/instrumental delivery. Induction of labor was attempt in 55 patients (49.1%). In regard to fetal complications; Low birth weight was documented in 6 neonates (5.4%), Respiratory distress syndrome 1 (0.9%), premature 3 (2.7%) and still birth 16 (14.3). The fetal death was documented on 17 patients (15.2%). There was no difference in the occurrence or types of neonatal complication in relation to the maternal diagnosis (P= .158 and P= .39) respectively, but there was a significant difference in the type of maternal diagnosis in relation to fetal death as the largest number of fetal deaths were reported in preeclampsia group (P=.02). On the other hand, the fetal complication appeared to be statically significant related to gestational week at diagnosis and delivery (P<0.001), but no significant association with maternal complications, age, multiparty, or mode of delivery. There was significant difference (P<0.001) in the laboratory parameters as improvement was noted in all parameters including platelets, hemoglobin level, creatinine, ALT, AST, bilirubin, alkaline phosphatase, GGT and albumin from the time of admission compared to one week later and compared to discharge time as well. LDH was significantly improved at time of discharge (P <0.001) but not after one week of diagnosis.

Table 1.

Age group and maternal complication

	Maternal complication					Total

	HEG	HELLP	Preeclampsia	Eclampsia	ICP
Age group (years)
<21	5	0	9	1	0	15
21-35	17	2	44	6	1	70
>35	0	1	25	1	0	27
Total	22	3	78	8	1	112

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HEG: Hyperemesis Gravidarum, HELLP: Hemolysis, elevated liver enzymes with low platelets, ICP: Intrahepatic cholestasis of pregnancy

Conclusion: In this retrospective study, we reported 112 cases of liver disease in pregnancy in King Abdulaziz University Hospital during the year 2017. The study showed significant relation between fetal death and maternal diagnosis of eclampsia. The fetal complication appeared to be statically significant related to gestational week at diagnosis and delivery, and the laboratory parameters significantly improved with delivery. It seems that there is undiagnosed cases due to lack of antenatal care is some society groups. Larger studies are needed at the national level for more elaboration of prevalence and behaviors of liver diseases in pregnancy.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/36: THE INFLUENCE OF INFLAMMATORY BOWEL DISEASE SYMPTOMS ON WORK AND SCHOOL ATTENDANCE: A CROSS SECTIONAL STUDY

Mahmoud Mosli ¹, Abdullah A Alamri ¹, Alia S Alamri ¹, Ahlam M Moafa ¹, Lamees H Aldoobie ¹, Yousif Qari ¹

Background: Inflammatory bowel diseases (IBD) are typically diagnosed at age periods during which patients have many academic and career related responsibilities. Given the burden that the disease can pose on patients’ quality of life, we aimed to evaluate the effect of IBD symptoms on work and school non-attendance in a cohort of Saudi patients with confirmed IBD.

Patients and Methods: We conducted a cross sectional survey of all patients diagnosed with IBD who regularly followed up at the outpatient GI clinic at King Abdulaziz University Hospital between January 2016 and December 2018. Patients who agreed to participate were surveyed about their demographics, disease characteristics, and disease activity. A questionnaire that focused on symptoms and their relationship with school and work attendance, and social commitments, was completed. Logistic regression analysis was used to identify determinants of school and work non-attendance.

Results: A total 136 patients were surveyed with a mean age of 32±16 years. Females comprised 51% of the cohort and the mean duration of symptoms was 12.8±8.2 years. Of the cohort, 52% had Crohn’s disease (CD) and 48% had ulcerative colitis (UC). Sixty-one patients (49%) were employed and 48 (35%) were students. Smoking was reported in 18% of participants and 12% had positive family history of IBD. While 45% of patients reported normal visits to the bathroom, 26% reported that they go extremely frequent with an average number of bowel movements of 3.3±1.9 per day. Fatigue was reported all the time, most of the time, and half of the time by 19%, 18%, and 13%, respectively. Thirty four percent of participants reported that they had to cancel a social event due to symptoms within the previous 2 weeks and 52% reported being troubled at least once during this period about not finding a bathroom. Furthermore, 42% reported having trouble during leisure or sports activities due to bowel movements and 56% had trouble having a good night sleep due to symptoms. 46% of employees and 42% of students reported absence from work and school within the past 2 weeks. According to logistic regression analysis, number of daily bowel habits (OR=1.8, 95%CI=1.3-2.6) and being unemployed (OR=0.17, 95%=0.03-0.9, p=0.04) significantly predicted absence from work or school.

Conclusions: Almost half of the patients in this cohort reported absence from school or work. The most significant predictor of non-attendance was the number of daily bowel habits.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/37: SURVEY TO ASSESS AND IDENTIFY WAYS TO INCREASE AWARENESS OF COLORECTAL CANCER IN SAUDIA ARABIA

Mona Khojah ¹, Masaheer Aljehani ¹, Daniah Allali ¹, Almoutaz Tayeb ¹, Sultan Albukhari ¹, Shadi Alkhayyat ¹

Background: Colorectal Cancer (CRC) has become a serious issue globally. In Saudi Arabia, it is the first cancer among male, third among female and the death rate was reported to be 8.3%. The main goal of CRC screening is to detect cancer in its early stages during its manageable stages. Therefore, our goal is to assess the public awareness of the CRC, determine the preferred method of screening, and explore the best way to do so.

Methods: A cross-sectional study was conducted in KAUH, Jeddah, Saudi Arabia, in 2016. Data was collected using an online questionnaire distributed through social media resulting in 4090 participants from all over the Kingdom. Statistical Package for Social Science Software (IBM SPSS Statistics 23) was used for data analysis using the Chi-square test.

Results: Majority of the respondents were Females (57.3%). (43.7%) choose unintentional weight loss as the most recognized symptoms of CRC. Smoking was the most recognized risk factor (69.6%), While Diabetes was the least acknowledged (18.1%). Majority of participants were not aware about CRC Screening methods and Social media educational contents was the preferred way of spreading awareness.

Conclusion: The study disclosed the low level of awareness among Saudi society regarding CRC symptoms, risk factors, and screening. That social media is the most preferred way of spreading awareness for most participants.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/38: UNDERSTANDING AND ATTITUDE OF PHYSICIANS AND GASTROENTEROLOGISTS REGARDING VIRTUAL REALITY IN THE HEALTHCARE SETTING – A SURVEY

Wael Kassem ¹, Salwa Masood ¹, Shahnaz Almiaari ¹, Iftikhar Ahmed ¹, Mohammad Rady ¹

Background: Virtual reality (VR) has started to make its way in health care setting. The integration of VR in various aspects of healthcare was emphasized by multiple studies. We conducted this survey to get a grasp of how physicians including gastroenterologists perceive VR, and their attitude regarding its applications in the healthcare.

Methods: 160 physicians of different backgrounds (gender, grade, specialty, and location), were approached through electronic means with a 10 questions survey. It was designed to get a holistic idea of how these physicians perceive VR in health care setting, their practical experience with the technology, and their attitude regarding the integration of VR in clinical practice. The survey also included questions as how this would influence the patient care and satisfaction.

Results: The response rate was 73.75% and the results showed that all the physicians (100%) were aware of VR and majority of them (80%) had some practical experience. All surveyed physicians (117/118) agreed on the importance and feasibility of introducing VR technology into healthcare setting. The similar percentage thought that both clinicians and patients would welcome its introduction in medical practice. However only 28% of these had doubts that the technology will improve patient experience and satisfaction.

Conclusion: There is a growing interest among clinicians and gastroenterologists regarding the integration of VR in clinical practice, but whether would it improve patient experience and quality of care remains a question of debate.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/39: SUCCESSFUL ENDOSCOPIC MANAGEMENT OF METALLIC STENT INDUCED BENIGN ESOPHAGEAL STRICTURE. CASE REPORT AND NOVEL ENDOSCOPIC INTERVENTION

Emad Aljahdali ¹, Ammar Aldabbagh ¹, Fatma Salah ¹

Fully-covered self-expandable metallic stents (FC-SEMSs) are commonly used to treat benign esophageal conditions including benign refractory strictures, anastomotic strictures, fistulae, perforations, and post gastric sleeve leaks. At present, the practice of using SEMSs in these settings remains nonstandardized. The adverse events associated with the placement of SEMSs are increasingly being reported, the practice of using SEMSs as well as and the management of these complications is not yet standardized.

Case Reports: Case 1: A 44 year-old-female with morbid obesity and fatty liver. She underwent gastric sleeve surgery at an outside medical facility. Her post-surgical course was complicated with pleural effusion, intra-abdominal hematoma and staple line leak necessitated placement of FC-SEMS. The stent was placed for three months then endoscopically removed with complete resolution of the leak. Four weeks post stent removal; she presented with progressive dysphagia to solids and liquids. Esophagogastroduodenoscopy (EGD) showed severe esophageal strictur that could not be traversed. Total of eleven endoscopic sessions was required to achieve a complete response, including a total of five endoscopic sessions of needle knife stricturoplasty mixed with CRE balloon dilation. The patient remains asymptomatic for over six months.

Case 2: A 46 year-old-male with morbid obesity. He underwent FC-SEMS insertion for post gastric sleeve leake at an outside medical facility. The stent was placed for seven weeks. Post stent removal, he developed progressive dysphagia to both solids and liquids. On presentation to our Emergency Department, he was unable to swallow his saliva. Esophagogastroduodenoscopy (EGD) showed complete obstruction of esophageal lumen. A Total of eight endoscopic sessions using CRE balloon dilation and needle knife stricturoplasty was performed in four months. The patient sustained an asymptomatic full recovery for over six months.

Conclusion: Up to our knowledge, we describe in this report the first two cases of stent-induced esophageal strictures leading to severe dysphagia post stent removal. Both patients underwent FC-SEMS placement for the management of post-gastric sleeve leaks. The stents were placed for over six weeks before they were removed. In the two cases, a full response to endoscopic management was achieved. Response to endoscopic CRE dilation and FC-SEMS was less effective compared to using CRE dilation with stricturoplasty with both patients remain asymptomatic for over six months. The placement of FC-SEMSs in benign conditions for a longer duration (over eight weeks), could be associated with the increased risk of developing symptomatic esophageal stricture.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/40: KNOWLEDGE AND ATTITUDES OF PRIMARY HEALTH CARE PHYSICIANS TOWARDS THE DIAGNOSIS AND MANAGEMENT OF INFLAMMATORY BOWEL DISEASE PATIENTS FOLLOWING AN EDUCATIONAL INTERVENTION: A COMPARATIVE CROSS SECTIONAL ANALYSIS

Rwan Alharbi ¹, Faizah Almahmudi ¹, Yahya Makhdoom ¹, Mahmoud Mosli ¹

Background: Inflammatory bowel disease (IBD) is a chronic inflammatory condition that requires early diagnosis and proper management. Patients with early symptoms of IBD are typically evaluated first by primary health care (PHC) physicians, who in turn refer patients with suspected IBD to specialists. Therefore, we aimed to assess the knowledge and attitude of PHC physicians towards IBD.

Materials and Methods: We conducted a comparative cross-sectional survey of PHC physicians practicing at ministry of health PHC centers in Jeddah, KSA. Demographics, and data on the knowledge and practices of physicians were collected through a pre-defined and tested questionnaire that included three domains (Eaden, Leong, and sign/symptom awareness). A subgroup of the cohort was educated about IBD referral criteria (Group A, n = 65) prior to study initiation and their responses were compared to those from the remaining group (Group B, n = 135). Regression analysis was used to test associations with the significance threshold set at 5%.

Results: A total of 202 PHC physicians were surveyed with a response rate of 99%. Females comprised 66.5% of the cohort and the mean age was 32.26±6.6 years. 91% of physicians were Saudi nationals, and 75.5% were MBBS degree holders. The majority of the respondents (93%) reported seeing zero to five IBD patients per month, and almost half of the physicians preferred to always refer patients to specialists (49.5%). Most of the respondents (40-70%) were uncomfortable with initiating or managing maintenance therapies (steroids, immunomodulators and biologicals) for patients with IBD. With regards to knowledge, group A had higher scores in all three domains especially in the sign/symptom awareness domain (mean score 6.17±1.1 vs. 3.5±1.01, p<0.001). According to multivariate analyses, the comfort of physicians in group B with IBD therapies, unlike those in group A, was influenced by IBD-related knowledge (OR = 0.606, 95% CI [0.389 – 0.944], p-value = 0.027). Qualifications appeared to significantly affect the comfort level of physicians with the usage of IBD therapies (OR = 0.1.721e-8, 95% CI [1.745e-9 – 1.698e7, p-value < 0.001).

Conclusion: The knowledge and comfort of PHC physicians with IBD medication prescription appears to be higher when education is provided. This observation is important since PHC physicians are responsible for early identification and referral of patients suspected of having IBD to specialists.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/41: UTILITY OF THIOPURINE METABOLITES IN GUIDING TREATMENT IN IBD - EXPERIENCE FROM A UNIVERSITY HOSPITAL

Fredrick G Ewbank ¹, Richard K Felwick ¹, Danyal Akarca ¹, Iftikhar Ahmed ^1,²

Background: Thiopurines are an important part of treatment in IBD. Measurement of thioguanine nucleotide levels has been shown to guide the optimisation of therapy with better clinical outcomes. It is less clear which patient groups benefit most from metabolite measurement. The aim of this study was therefore to determine the clinical utility of thiopurine metabolite measurement in a cohort of IBD patients from a university hospital.

Methods: IBD patients who had thiopurine metabolites measured between 2016 and 2018 were identified. Demographic data, reason for testing, metabolite measurements and outcome were recorded by retrospective clinical notes review.

Results: 141 patients were identified (44 UC, 97 CD). A total of 210 Metabolite measurements were made, active disease 103/210 (49%), inactive disease 44/210 (21%) or other indications in 64/210 (30%). Patients with active disease had their treatment optimised in 63/103 (61.2%). Metabolite measurement had the least clinical utility in those with inactive disease. From 43 measurements, 71% resulted in no change to treatment. Overall 50% of these resulted in no change in clinical management. Measurement for dose optimisation, side effects or consideration of stopping a biologic resulted in changes to treatment in 51.4, 50 and 0% respectively.

Conclusion: Metabolite measurements in patients with active IBD show the greatest clinical utility in term of treatment optimisation and better clinical outcome, and should be restricted to these groups.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/42: DIET LOW IN FODMAPS REDUCES SYMPTOMS OF PATIENTS WITH NON-CELIAC GLUTEN SENSITIVITY

Georgios Zacharakis ¹, Jamman Mohamad S Alzahrani ¹, Sameer Al-Ghamdi ², Abdullah Abdurahman Ahmed Altuwaim ¹, Khalid Saeed Abdullah Alghamdi ¹, Naif Metrek N Alqahtani ¹, Abdalrahman Mahamad Saeed Aldossary ¹, Khalid Abdulrahman Muaigel Albassam ¹, Mohammed Ibraheem Alnafeesah ¹

Background: In individuals with self-reported non-celiac gluten sensitivity (NCGS), fructans rather than gluten induced symptoms. We investigated the specific effects of diet low in fermentable, poorly absorbed, short-chain carbohydrates (fermentable, oligo-, di-, monosaccharides, and polyols [FODMAPs]) in subjects believed to have NCGS.

Methods: A single-blind study of 43 patients with self-reported NCGS who met Rome IV criteria for IBS were registered at gastroenterology outpatient clinic at the University Hospital of the Prince Sattam Bin Abdulaziz University, in Al Kharj. Those individuals were randomly assigned to two groups; one had-a diet low in FODMAPs (n = 23) for 4-weeks and the other group had a gluten free diet (n = 20). Symptom severity was assessed using the IBS Symptom Severity Scale, and patients completed a 4-day food diary before and at the end of the intervention.

Results: A total of 40 patients completed the dietary intervention; 21 completed the diet low in FODMAPs, 19 completed the gluten free diet. The severity of IBS symptoms was reduced in both groups during the intervention (P < .0001 in both groups before vs at the end of the 4-week diet), without a significant difference between the groups (P = .73). At the end of the 4-week diet period, 10 patients (50%) in the low-FODMAP group had reductions in IBS severity scores ≥50 compared with baseline vs 8 patients (42%) in gluten-free diet group (P = .72). Food diaries demonstrated good adherence to the dietary advice.

Conclusions: A diet low in FODMAPs reduces in self-reported NCSG-IBS symptoms as well as traditional gluten free dietary advice, probably as a consequence of wheat elimination.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/43: NORMALIZATION OF ANTI TISSUE TRANS-GLUTAMINASE ANTIBODIES IN PATIENTS WITH HISTOLOGICALLY CONFIRMED CELIAC DISEASE: A RETROSPECTIVE ANALYSIS

Hani Jawa ¹, Hatim Khatib ¹, Ibrahim Almani ¹, Abdulaziz Etaiwi ¹, Abdulrahman Alharbi ¹, Abdulaziz Ajaj ¹, Rana Bokhary ¹, Yousef Qari ¹, Mahmoud Mosli ¹

Background: Celiac disease (CD) requires strict adherence to a gluten free diet to avoid impact on health. We aimed to evaluate the relationship between patient follow up and normalization of anti-tissue trans-glutaminase antibody (anti TTG) and identify predictors of normalization.

Patients and Methods: Single center, retrospective analysis of adult patients with confirmed CD based between 2013 and 2018.

Results: Seventy-eight patients fulfilled the study criteria. Average age was 30.2 (±12) years. Females comprised 58% of the cohort and 72% were Saudis. The most common presentation was anemia (45%) followed by abdominal pain (27%) and weight loss (19%). Mean anti TTG at baseline was 242±501.5. Iron deficiency was reported in 60% and Osteoporosis in 22%. Mild and severe villous atrophy were noted in 37% and 47% of biopsy samples. 67% of patients were seen in clinic after diagnosis (of which 75% had anti TTG repeated). Anti TTG normalization was achieved in 29% of patients of whom 43% occurred during first of year of follow up. Out of the patients that had repeat anti TTG done, 47% had proven normalization. Patients who were seen in clinic at least once after diagnosis were more likely to normalize anti TTG (8% vs. 40%, p = 0.003). Normalization was significantly predicted by baseline anti TTG value (OR=0.99, 95%CI=0.98-0.99) and follow up in the GI clinic (OR=19, 95%CI=2.4-142).

Conclusions: A significant proportion of patients diagnosed with CD achieve normalization of celiac serology. Adherence to follow up after diagnosis is strongly predictive of biochemical remission.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/44: OVARIAN CROHN’S DISEASE: A CASE REPORT AND REVIEW OF THE LITERATURE

Hamza Mohammed ¹, Mahmoud Mosli ¹, Mohammed Nassif ¹, Rana Bokhary ¹

Case Presentation: Crohn’s disease is an inflammatory bowel disorder that is progressive in nature, resulting in certain complications as fistulization or stricture formation, that once developed may require surgical intervention. The clinical picture includes gastrointestinal symptoms as abdominal pain, weight loss and diarrhea, in addition to systemic manifestations such as joint pain and skin involvement. The age group for CD varies from childhood to older age groups, but most commonly diagnosed between 15 and 30 years. The prevalence of CD has been increasing over the past 30 years, most commonly affected site is the ileo-cecal region. There are no firm diagnostic features for CD but typical signs include: perianal fistulas, large skin tags or abscesses on physical examination; small bowel involvement, mucosal ulceration, cobble stoning, narrowing, obstruction, and fistulas seen on cross sectional imaging and endoscopically. Histopathological features suggestive of CD include non-caseating granulomas and transmural lymphoid aggregates, which is often only noticeable after examining a resected part of the bowel. Differentiating CD from intestinal tuberculosis remains a diagnostic challenge and often results in a delay in the diagnosis and treatment. In this report, we present to you a rare case of ovarian involvement of Crohn’s disease in a 28 year old nulligravida Eritrean patient, it’s a rare manifestation of Crohn’s, believed to be from the fistulization between the ovaries and the intestines, where the biopsy of the ovary showed Crohn’s features.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/45: HUMAN PAPILLOMA VIRUS BOWEL COLONIZATION IN INFLAMMATORY BOWEL DISEASE: IS THERE AN ASSOCIATION?

Mahmoud Mosli ¹, Marwan Albeshri ¹, Haneen Alabsi ¹, Abdullah Albishri ¹

Background: The relationship between Human papilloma virus (HPV) colonization of the GI tract and development of inflammation is not well understood. Nevertheless, HPV has been implicated in the pathogeneses of many diseases including gastrointestinal malignancies. We aim to investigate the prevalence of HPV colonization in the lower GI tract in patients with inflammatory bowel disease (IBD) and if possible its association with disease activity.

Patients and Methods: We performed a prospective observational study involving patients with confirmed IBD referred to the endoscopy unit at King Abdulaziz University for endoscopic evaluation between January 2017 and December 2018. During endoscopy, endoscopic disease severity and disease location were first recorded. A biopsy sample was then collected from the most inflamed colonic or ileal segments. The Hybrid Capture assay was used to detect tissue HPV. Prevalence of HPV colonization was calculated, and association between HPV presence and IBD endoscopic activity was sought.

Results: A total of 117 IBD patients were recruited and examined of which 62 (53%) were females. Fifty-two patients (44.4%) had CD and 63 (53.4%) had UC. Average age was 32.2±12.7 years and average duration of illness was 3.8±4.0 years. The commonest area of disease involvement was the recto-sigmoid in 54.3% of cases and 57 (54.8%) patients had endoscopic evidence of active disease. All biopsy samples taken for HPV detection were reported as negative for HPV.

Conclusions: In this cohort of patients with IBD we could not detect any evidence of HPV colonization in active or inactive bowel segments; therefore concluding that HPV colonization plays no role in inflammatory bowel disease activity.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/46: CHARACTERISTICS AND OUTCOME OF PATIENTS TRANSPLANTED FOR NON ALCOHOLIC STEATOHEPATITIS RELATED CIRRHOSIS

Sarra Yousif ¹, Mohamed Shawkat ¹, Issam Saleh ¹, Hazem Hasan ¹, Waheed Ullah ¹, Faisal A Abaalkhail ¹, Abdallah Al-osaimi ¹, Mohammed Alsebayel ¹, Dieter Broering ¹, Khalid Bzeizi ¹, Hussien A Elsiesy ¹, Waleed Al Hamoudi ¹

Background: Nonalcoholic fatty liver disease (NAFLD) has emerged as the most common chronic liver disease worldwide. Our aim was to evaluate the prevalence of metabolic syndrome and long term outcome of patients transplanted for NASH related cirrhosis.

Methods: All patients transplanted for NASH related cirrhosis at our institution from 2001-2016 were included in this study.

Results: 108 (77 males and 31 females) patients were transplanted for NASH-related cirrhosis at our institution. Sixteen (15%) patients had pretransplant hepatocellular carcinoma. Pretransplant obesity (BMI>30), diabetes, hyperlipidemia and hypertension were present in 43 (40%), 57 (53%), 20 (19%), and 30 (28%) patients, respectively. Following LT patients were followed for an average of 56 months (range 7-156 months). Post-transplant diabetes, hyperlipidemia and hypertension were present in 62 (57%), 25 (23%) and 48 (44%) patients, respectively. 50 (46%) patients developed renal impairment (GFR <60) during follow up period. 39 (36%) patients developed disease recurrence with significant fatty infiltration on various imaging modalities. Diabetes, hyperlipidemia and hypertension in patients with post-transplant disease recurrence were 30 (77%), 16 (41%) and 24 (62%), respectively. Additionally, severe renal impairment (GFR<50) was more common in patient with disease recurrence (44% vs 28%). Sixteen patients were treated for mild rejection and only one patient developed ductopenic rejection resulting in graft loss. Six patients developed severe cardiovascular complications. Overall survival during the follow period was 89%.

Conclusion: Disease recurrence in our patient population was common; however, post-transplant cirrhosis remains rare. The prevalent metabolic syndrome negatively impacted renal function and resulted in cardiovascular complication.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/47: THE EFFECT OF ERCP NURSE EXPERIENCE ON PROCEDURE DURATION

Bahaa Bseiso ¹, Mahmoud Mosli ¹, Turki AlAmeel ¹

Background: ERCP is a technically challenging procedure. Over the years, the role of nurses in endoscopy has expanded. In one study by (Dellon ES et al 2009), they found that GI endoscopy nurse inexperience was associated with an increase in immediate complications & prolonged colonoscopy procedure times. In this study, we aim to examine whether the level of experience of endoscopy nurse will have an impact on the ERCP duration.

Methods: This is a single center, retrospective analysis of all ERCP procedures performed at a tertiary care referral center with a high volume endoscopy unit between 2012 and 2018. Procedures were excluded if a training fellow was involved. Procedures were performed by five endoscopists; an experienced group with >15 years experience in the field & two junior endoscopists with <five years experience. Nurses were also divided into two groups based whether they have more or less than 10 years experience in ERCP. The primary outcome of the study was the correlation between endoscopy nurse experience and procedure duration. Secondary outcomes included success of cannulation, complication and technical difficulty.

Results: The final analysis included 860 ERCPs. We found no significant difference association between the duration and the level of experience of the nurse involved. This remained the case with simple and multiple linear regressions [Tables 1 and 2].

Table 1.

Predictors of procedure duration based on simple and multiple linear regression

Predictor	Simple coefficient (95% CI)	Multiple coefficient (95% CI)
Endoscopist experience	−10.2 (−39.6-19.1)	−12.4 (−41.9-17.2)
Nurse experience	−10.6 (−40.3-19.1)	−11.7 (−41.5-18.1)
Indication	3.9 (−4.0-11.8)	3.85 (−4.1-11.8)
Cannulation	17.2 (2.35-32.0)	16.7 (1.9-31.6)
Complication	58.1 (−86.0-202.1)	65 (−79.3-209.3)

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CI: Confidence interval

Table 2.

Predictors of procedure related complications based on simple and multiple logistic regression

Predictor	Simple OR (95% CI)	Multiple OR (95% CI)
Endoscopist experience	8.7 (1.1-69.8)	9.3 (1.2-75.5)
Nurse experience	1.7 (0.5-6.5)	2.1 (0.5-7.9)
Indication	1.1 (0.7-1.6)	1.0 (0.7-1.5)
Cannulation	0.9 (0.5-1.8)	0.9 (0.9-1.0)
Procedure duration	1.0 (0.9-1.0)	1.0 (0.00002-0.02)

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OR: Odds ratio, CI: Confidence interval

Conclusion: This retrospective study shows that the nurse’s experience in assisting in ERCP had no influence on the duration of the procedure. This did not change whether the endoscopist involved was a senior or junior attending.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/48: PREDICTING THE CLINICAL COURSE AND BEHAVIORS OF INFLAMMATORY BOWEL DISEASE BY METABOLOMIC ANALYSIS

Iftikhar Ahmed ¹, Wael Kassem ¹, Fredrick Ewbank ¹, Danyal Akarca ¹, Manuele Furnari ¹

Background: The assessment of disease activity in inflammatory bowel disease (IBD) remains challenging and requires invasive and expensive investigations. Volatile organic metabolites (VOMs) are chemicals which are emitted in the biological excretions and are responsible for its distinct odor. Pattern analysis of these (VOMs) may provide a non-invasive way of understanding disease behavior in IBD.

Methods: We aimed to investigate faecal VOMs in predicting the clinical course and activity of IBD. 205 individuals were studied, 75 with active IBD (CD=46, UC=29), 70 with disease in remission (CD=35, UC =35) and 60 healthy controls. Diagnosis was confirmed histologically; and disease location, extent and activity were established using endoscopic and radiological findings and clinical scoring. Faecal VOMs were extracted using solid phase micro-extraction and analysed by gas chromatography/mass spectrometer.

Results: A total of 253 VOMs were identified using NIST library. Discriminant function analysis showed different profile of patients with colonic compared to small bowel CD, limited UC from pan UC, and active IBD from normal controls with a sensitivity of 85% and specificity of 90%. This was further revalidated using 80:20 splits repeated 10 times. Profiles of patients in disease remission were similar to healthy controls.

Conclusion: Our findings suggest that volatile analysis can predict the activity and behaviour of IBD. These observations and further data analysis may provide more insight into the aetiopathological processes in IBD which may lead to diagnostic and therapeutic developments in future.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/49: PREVALENCE OF IRRITABLE BOWEL SYNDROME IN SAUDI ARABIA, PREDICTORS AND ITS IMPACT ON LIFE STYLE DUTIES

Georgios Zacharakis ¹, Jamaan AlZahrani ¹, Abdullah Abdurahman Ahmed Altuwaim ¹, Moaz Hassan Alharbi ¹, Manal Mahmood Alsalmi ², Sultan Bander Alotaibi ³, Yasmeen Abdullah Algaradi ¹, Fatimah Nassir Alsadiq ³, Pavlos Nikolaidis ⁴

Background: Irritable bowel syndrome (IBS) is a high prevalent gastrointestinal disorder and can change the quality of life and cause economic burden. Few studies have been done concerning IBS among the general population of Saudi Arabia and it’s impact on life. The aim of this study is to determine the prevalence of IBS among the Saudi population in Saudi Arabia, the possible predictors, and it’s impact on life duties.

Results: 3120 adult individuals were randomly selected. Of them, 1760 (56.4%) agreed to participate. 22.9% of respondents reported highly frequent IBS symptoms with mean age of 27.5 ± 3 years and range of 18-59 years. The prevalence of IBS-Mixed type was the commonest variety (57.5%) with a higher prevalence among females (Prevalence risk ratio of female: male is 1.43). Positive family history of IBS, unemployed, poor sleep quality, and high anxiety and depression scale scores were significantly associated with IBS. After controlling for confounding factors in regression analysis, the predictors of IBS were food intolerance (aOR=3.41; 95% CI: 1.6-10.23), anxiety/depression (aOR=3.34; 95% CI: 1.38-11.36), and positive family history of IBS (aOR=2.29; 95% CI: 1.11-11.37). The IBS symptoms significantly affect the work performance of the Saudis (43.3%) with high absenteeism rate (36.2%).

Conclusion: The prevalence of IBS was 22.9%. Food intolerance, anxiety/depression, and family history were the predictors of IBS. Majority of Saudis with IBS symptoms are having frequent problems with the usual life duties.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/50: THE UTILIZATION PATTERNS AND COSTS OF BIOLOGICS IN THE MANAGEMENT OF INFLAMMATORY BOWEL DISEASE AMONG A SAMPLE OF PATIENTS IN SAUDI ARABIA: A SINGLE-CENTER CROSS-SECTIONAL STUDY

Yazed AlRuthia ¹, Majid A Almadi ¹, Abdulrahman M Aljebreen ¹, Nahla A Azzam ¹, Ohud H Bahari ¹, Khalid A Almalki ¹, Abdulaziz T Atham ¹, Ahmed S Alanazi ¹

Background: The advent of biologics has revolutionized the treatment of Inflammatory Bowel Disease (IBD) and increased the financial burden on the health sector, however, data that describe their utilization patterns and costs are scarce in Saudi Arabia. Therefore, the aim of this study was to describe biologic drugs’ utilization patterns and costs among a sample of IBD patients in Saudi Arabia.

Methods: Data were retrieved from the electronic medical records of a university-affiliated tertiary care hospital in Riyadh, Saudi Arabia as of October 2018. The acquisition costs were retrieved from the Saudi Food and Drug Authority’s drug prices database. The cost of laboratory tests and other relevant cost items such as the Intravenous infusion were taken from the cost center in the own resources department at the Saudi ministry of health.

Results: Out of 507 reviewed medical records of IBD patients, 258 had Crohn’s Disease (CD) and 249 had Ulcerative Colitis (UC). Approximately 42% of the patients were on biologics and the majority of them (74.42%) were CD patients. The utilization of six biologics (infliximab, adalimumab, certolizumab, ustekinumab, vedolizumab, and golimumab) were identified. The CD patients had significantly higher utilization rates compared to UC patients of infliximab (37% vs. 11.24%, P<0.0001), adalimumab (21% vs. 9.64%, P<0.0006), and certolizumab (6% vs. 0%, P<0.0001). The annual utilization costs of these six biologics ranged from SR 20,840.85 for ustekinumab to SR 69,203.23 for vedolizumab.

Conclusion: Future studies should examine the cost effectiveness of different biologics in the management of IBD in Saudi Arabia.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/51: SCREENING AWARENESS AMONG FIRST DEGREE RELATIVE OF COLORECTAL CANCER PATIENTS AT KING ABDULAZIZ UNIVERSITY HOSPITAL, JEDDAH, SAUDI ARABIA

Emad Aljahdali ¹, Masaheer Aljehani ¹, Sondos Aljehani ¹, Rahaf Bahomeed ¹, Lujain Bahakeem ¹, Yosra Badahdah ¹, Khawlah Alshanqiti ¹, Rasha Alharbi ¹

Background: In the Kingdom of Saudi Arabia (KSA), colorectal cancer CRC was the first cancer in terms of incidence among men and the third among women in 2014. There were 1033 cases of CRC diagnosed in 2010. This number increased to 1347 in 2014. Riyadh, the capital city of Saudi Arabia, was the highest region regarding CRC incidence. Approximately, 20% of all patients diagnosed with CRC have a family history of first or second-degree relatives diagnosed with the disease. Patients diagnosed with CRC under the age of 60 years are considered a high-risk group. Screening of their first-degree relatives would help lower disease-related mortality. However, screening rates remain as low as 32% in this group of individuals. In this study, we aim to determine the level of awareness of CRC screening in this group at King Abdul-Aziz University Hospital (KAUH).

Methodology: A cross-sectional study was conducted in 2017 on first-degree relatives of CRC patients diagnosed at the age of younger than 60 years. Total of 87 first-degree relatives was involved in the study. A questionnaire designed to assess the level of awareness about available screening tests and risk factors related to CRC development was used.

Results: Regarding the level of awareness, 63.2% did not think they are at higher risk of developing CRC compared to the average population. Although 71.3% believe there are available screening modalities for CRC, the majority did not undergo screening due to several reasons. The two main reasons were lack of awareness about the importance of screening (42.5%), and fear of examination results (28.7%).

Conclusion: From our study, we conclude that in our community there is a lack of awareness about the importance of CRC screening among the first-degree relatives of CRC patients younger than 60 years. Several factors could be contributing to this issue such as lack of awareness campaigns and physician education of patients’ relatives about the need for screening and available tests. These measures could result in decreasing disease mortality in this high-risk group.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/52: RESISTANCE TO CEFTRIAXONE AMONG CIRRHOTIC PATIENTS ADMITTED WITH SPONTANEOUS BACTERIAL PERITONITIS

Hatim Khatib ¹, Hind Fallatah ¹, Hisham Akbar ¹, Majid Alsahafi ¹

Background: Spontaneous bacterial peritonitis (SBP) is a major cause for morbidity and mortality among patients with decompensated liver cirrhosis. Third generation cephalosporins are recommended as the antibiotic treatment of choice. The aim of this study is to determine the prevalence of resistance to ceftriaxone among cirrhotic patients admitted with SBP.

Methods: We retrospectively reviewed the hospital records at an academic hospital for all cirrhotic patients admitted with SBP between 2008 and 2017. SBP was diagnosed when the polymorphonuclear leukocytes (PMN) count is > 250 with or without positive culture. Clinical and laboratory data was collected. The mean and standard deviation and/or the median with range were used for continuous variables as appropriate. The percentage and count were used for categorical variables.

Results: A total of 102 patients admitted with SBP were included. The mean age was 57.1 (± 15), and 67 (65.6%) were male. HCV was the most common cause for cirrhosis (44.1%), followed by NASH (17.6%) and HBV (14.7%). The mean albumin, INR and total bilirubin were 20.7 g/L (±13.2), 1.8 (±0.8) and 91.4 umol/L (± 111) respectively. The median ascitic fluid PMN was 1850 (range 273, 37973). The ascitic fluid culture was positive in 44 (43.1%) patients. Among the 44 patients with positive culture, resistance to ceftriaxone was detected in 16 (36.3%) patients.

Conclusions: Positive bacterial culture was seen in 43% of patients admitted with SBP, with 36.3% prevalence of microbial resistance to ceftriaxone.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/53: THE ROLE OF WHEAT GERM OIL IN EXTENUATING THE TOXIC EFFECTS OF MALATHION ON HEPATIC FUNCTION IN MALE ALBINO RATS

Maha I Alkhalf ¹

Background: Malathion is a widely used organophosphorus insecticide applied widely for agricultural purposes. This study aims to evaluate the antioxidant efficiency of wheat germ oil WGO in malathion-encouraged liver damage in male albino rats.

Methods: Thirty-six rats were divided into three groups as follows: G1: control fed on basal diet, G2 rats: malathion was supplemented to basal diets at a dose 100 mg/kg diet. G3: rats fed malathion containing diets and supplemented with wheat germ oil at a dose of 400 mg/kg diet.

Results: The study represented that malathion induced liver damage was marked by increased liver function tests, disturbed antioxidant status and light microscopic analysis exhibiting histological alterations in liver sections. Whereas, dietary supplementation with wheat germ oil brought liver enzymes near normal levels and reduced oxidative stress due to its vitamin E content and other contents of antioxidant power.

Conclusion: Wheat germ oil is considered as a hepatoprotective agent against malathion toxicity.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/54: ILLNESS COGNITION OF PATIENTS WITH CROHN’S DISEASE: A CROSS SECTIONAL SURVEY

Mahmoud Mosli ¹, A Saeedi ¹, N Bawahab ¹, L Abdu ¹, S Alshobai ¹, Hani Jawa ¹, Majed Alsahafi ¹, Emad Aljahdli ¹, Yousef Qari ¹

Background: Patients awareness of the chronic nature of Crohn’s disease (CD) can lead to a wide range of psychological concerns. Patients’ cognition about the disease course and treatment is an important mediator that can account for individual differences in the ability to adjustment to chronic disease. We aimed to evaluate illness cognition of patients with CD.

Patients and Methods: We conducted a cross sectional survey of patients with CD following up at outpatient GI clinic at King Abdulaziz University Hospital (KAUH), Jeddah, Saudi Arabia; between January and December of 2018. Patient demographic and disease characteristics were collected. Patients were interviewed using a validated questionnaire focusing on disease cognition and coping with symptomatology and disease course.

Results: Sixty patients with CD and a mean age of 27.8±7.2 were interviewed. Females constituted 57% of the cohort and 85% were Saudi’s. Mean duration of illness in months was 59±65 and 20% were smokers. 8/60 (13%) reported previous surgeries and 6/10 (60%) had perianal disease. While 48% believed that dealing with their illness made them a stronger. 15% felt that the disease controlled their life. 20/60 (33.3%) believed that being diagnosed with CD made life feel more precious and 14/60 (23.3%) reported that the illness didn’t prevent them from doing what they would really like to do. 8/60 (13.3%) reported that they couldn’t cope with their illness.

Conclusions: Patients with CD demonstrate various degrees of cognition and coping with their illness. Further studies are needed to better understand factors that determine these variations.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/55: THE PREVALENCE OF IRRITABLE BOWEL SYNDROME AMONG BOARD CERTIFIED MEDICAL DOCTORS IN SAUDI ARABIA

Turki AlAmeel ¹, Lee S Roth ¹, Eman Al Sulais ¹

Background: Irritable bowel syndrome is one of the most common functional gastrointestinal disorders. A pooled analysis showed a global prevalence of 11.2%. Health care providers represent a distinct part of society. Their careers are perceived as stressful with specific challenges. The aim of this study was to determine the prevalence of IBS among board certified physicians and surgeons.

Methods: Board certified physicians and surgeons in Saudi Arabia were invited to complete a web based survey. The Rome IV questionnaire was used to identify subjects with IBS. The primary outcome of the study was the prevalence of IBS among physicians. Secondary outcomes included exploring the effect of age, gender, marital status, work hours, specialty, and working in a public versus private hospital.

Results: The final analysis included 594 subjects, with 419 males and a median age of 41. The vast majority (86%) were married. Nearly 90% worked in a public hospital exclusively, and the median number of hours worked per week was 48. The overall prevalence of IBS was 16.3%. In a binary logistic regression model, age (OR = 0.931, p<0.0001), gender (OR = 0.504, p=0.003) and work hours (OR 2.397, p<0.0001) significantly predicted the presence of IBS. Marital status and specialty did not predict IBS prevalence.

Conclusion: This study shows that the prevalence of IBS among Saudi physicians to be 16.3%. IBS was more common in females, those who worked longer hours and younger physicians. There was no association between practicing certain specialties and IBS.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/56: PRELIMINARY EFFICACY AND SAFETY OF 8-WEEK GLECAPREVIR/PIBRENTASVIR IN PATIENTS WITH HCV GENOTYPE 1–6 INFECTION AND COMPENSATED CIRRHOSIS: THE EXPEDITION-8 STUDY

Robert S Brown Jr ¹, Christophe Hezode ¹, Stanley Wang ², Maria Buti ³, Wan-Long Chuang ⁴, Humberto Aguilar ⁵, Gábor Horváth ⁶, Barbara Rosado Carrion ⁷, Federico Rodriguez-Perez ⁸, Eric Cohen ², Yiran B Hu ², Gretja Schnell ², Chih-Wei Lin ², Lino Rodrigues ², Roger Trinh ², Federico J Mensa ², Franco Felizarta ⁹

Background: The pangenotypic direct-acting antivirals glecaprevir (identified by AbbVie and Enanta) coformulated with pibrentasvir (G/P) are approved to treat chronic HCV genotype (GT) 1–6 infection. Eight-week G/P achieved high SVR12 rates in Phase 2 and 3 studies, but was not studied in patients with compensated cirrhosis. Based on the high SVR12 rates demonstrated in treatment-naïve patients with HCV GT1-6 infection and compensated cirrhosis treated with 12-week G/P, this study evaluates the efficacy and safety of an 8-week G/P treatment duration in that population.

Methods: EXPEDITION-8 is an ongoing phase 3, non-randomized, single arm, open-label, multicenter study conducted in adults with chronic HCV GT1–6 infection with compensated cirrhosis who are HCV treatment-naïve. A recently approved protocol amendment enabled the inclusion of HCV GT3-infected patients, who are not included in this analysis. G/P (300 mg/120 mg) is being dosed orally once-daily with food for 8 weeks. The primary efficacy endpoint is the SVR12 rate. Secondary endpoints are on-treatment virologic failure and relapse rates. Adverse events and clinical laboratory abnormalities are being monitored in all patients.

Results: In total, 280 treatment-naïve patients with compensated cirrhosis have enrolled and are included in the analysis. The majority of patients were white (80%), male (60%), and with a Child-Pugh score of 5 (90%); the distribution of genotypes were as follows: GT1 (82%), GT2 (9%), GT4 (5%), GT5 (<1%), and GT6 (3%). At baseline, median and range values for key characteristics were as follows: HCV RNA 6.3 (3.4–7.5) log₁₀ IU/mL, FibroScan score 20.7 (2.5–70.6) kPa, platelet count 152 (42–788) × 10⁹ cells/L, total bilirubin 0.7 (0.2–2.4) mg/dL and albumin 4.2 (2.7–5.1) g/dL. To date, 116 patients have completed the post-treatment week 12 visit; [Figure 1] shows preliminary efficacy results for those with available post-treatment week 4 and/or 12 data. No virologic failures have occurred. Adverse events (AEs) have been mostly mild, with the most common (at least 5%) AEs being pruritus and fatigue (both 9%), headache (7%) and nausea (6%). No AEs have led to discontinuation of G/P; 5 serious AEs have occurred, none of which were deemed related to G/P.

Conclusion: In this ongoing study, G/P for 8 weeks in treatment-naïve patients with HCV infection and compensated cirrhosis has been well-tolerated and achieved high rates of SVR, with no virologic failures to date. Updated efficacy and safety data will be presented at the meeting.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/57: CORRELATION BETWEEN PHYSICIAN AND PATIENT DIRECTED DISEASE ASSESSMENTS IN ULCERATIVE COLITIS: BASELINE DATA FROM THE ICONIC STUDY OF PATIENTS FROM SAUDI ARABIA AND EGYPT

Othman R Alharbi ¹, Yousef A Qari ¹, Ali Anwar ², Mahmoud H Mosli ³

Background: “Understanding the Impact of Ulcerative COlitis aNd Its assoCiated disease burden on patients (ICONIC)” is a prospective, multi-country, observational study, that was conducted to assess disease burden in ulcerative colitis (UC) patients.

Methods: This is a subgroup analysis of baseline data of patients that were enrolled in Saudi Arabia and Egypt. Adult UC patients (diagnosed ≤ 36 months) were enrolled irrespective of disease severity or treatment. Tools for patient-reported outcomes (PRO) included Pictorial Representation of Illness & Self-Measure (PRISM), Patient Health Questionnaire-9 (PHQ-9), Short Inflammatory Bowel Disease Questionnaire (SIBDQ) and Patient-Modified Simple Clinical Colitis Activity Index (P-SCCAI). Physician assessment included clinical parameters, PRISM and SCCAI. Correlations between self-assessment scores were evaluated using Pearson correlation.

Results: Data from 53 (out of 100) patients were analyzed. Mean (± SD) age was 30.2 (± 9.2) years. 69.8% of patients (n = 37) had symptoms for < 1 year before receiving a diagnosis of UC. Of note, 28.3% of patients (n=15) were diagnosed with an extra intestinal manifestation. 96.2% of patients were on a treatment. 67.9% of patients reported to have moderate or severe disease while physicians assessed 58.5% to have moderate or severe disease. Patient-reported disease burden (P-SCCAI) was higher compared to physician assessment (SCCAI) (5.1 ± 3.6 vs. 2.9 ± 2.9). Also patient-reported PRISM scores were lower than physician-assessed PRISM scores (3.6 ± 2.4 vs. 4.8 ± 2.3). Patient-reported PRISM scores moderately correlated with SIBDQ, P-SCCAI and PHQ-9 [Table 1].

Table 1.

Patient-reported outcomes: correlation of novel, patient-assessed pictorial representation of illness and self-measure with established tools short inflammatory bowel disease questionnaire, simple clinical colitis activity index and patient health questionnaire-9

Variables	Number of patients	Pearson correlation coefficient	P
PRISM (patient) versus SIBDQ (patient)	50	0.60	<0.0001
PRISM (patient) versus PHQ-9 (patient)	50	−0.59	<0.0001
PRISM (patient) versus P-SCCAI (patient)	50	−0.44	0.0015

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SIBDQ: Short Inflammatory Bowel Disease Questionnaire, PRISM: pictorial representation of illness and self-measure, P-SCCAI: Patient-Modified Simple Clinical Colitis Activity Index, PHQ-9: Patient Health Questionnaire-9

Conclusions: In this analysis of patient data in the ICONIC study, nearly all patients received therapy; however, over half of the patients still had moderate to severe active disease. Patient-reported PRISM scores, measured for the first time in a population of patients with UC, moderately correlated with IBD-specific PRO tools (SIBDQ, P-SCCAI), and general depression assessment PHQ-9. Differences in perceptions of UC-related burden between physician- and patient- assessment may reflect insufficient patient-physician communication. As an adjunct to standard measures of disease assessment, PRISM may serve as a tool for improving patient-physician communication.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/58: PREDICTOR OF LONG TERM OUTCOME OF COMPLEX FISTULISING CROHN’S DISEASE TREATED WITH ANTI-TUMOUR NECROSIS FACTOR-ALPHA AGENTS BASED ON PARKS CLASSIFICATION

Nahla Azzam ¹, Majid Almadi ¹, Othman Alharbi ¹, Mahmoud Mosli ¹, Vito Annese ², Alabbas Mohammed ¹, Salman Bahammam ¹, Ahmed Bashmail ¹, Yasser Alomar ¹, Abdulrahman Aljebreen ¹

Background: Perianal fistulising Crohn’s disease (PFCD) carries a significant diasability. Data assessing healing of complex PFCD based on pelvic magnetic resonance (MRI) using Parks’ classification remains sparse. We aimed to assess the efficacy of infliximab and adalimumab in the treatment of complex PFCD based on Parks’ classification and identify the factors that predict the response.

Methods: All patients registered in the Inflammatory Bowel Disease Information System, who were diagnosed with complex PFCD based on MRI and treated with infliximab or adalimumab were retrospectively identified. Response to treatment was determined as full, partial, or no response, based on Parks classification, after at least 12 months of treatment.

Results: Of 960 patients identified 61 with complex PFCD were included. The median age was 27 years (range: 14 to 69 years) and with a median duration of disease of 6.2 ± 5.8 years. A full response was achieved in 27 (44.4%), whereas 10 (16.3%) had a partial response while 24 (39.3%) had no response. On univariable analysis a statistically significant association was observed between poor fistula response and low BMI, anorectal involvement, fistulae classification, and presence of an abscess. Whereas on multivariable regression only low BMI predicted poor fistulae outcome with odds ratio 1.37 (95% confidence interval, 0.69-0.98). There was no difference in the response when comparing infliximab or adalimumab.

Conclusion: Less than half of patients achieved complete fistulae healing. There was no significant difference between adalimumab and infliximab in treatment efficacy for complex PFCD and only low BMI predict the poor fistulae outcome.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/59: A RANDOMIZED OPEN-LABEL TRIAL OF PARITAPREVIR PLUS RITONAVIR PLUS OMBITASVIR IN THE TREATMENT OF HCV GENOTYPE 4-INFECTED PATIENTS WITH STAGE 4-5 CHRONIC KIDNEY DISEASE

Faisal M Sanai ^1,², Mohammed A Babatin ³, Mohammed Qaseem Khan ⁴, Hamdan Alghamdi ⁵, Khalid Alswat ², Ahmed Alqahtani ⁶, Abdullah S Alghamdi ³, Hassan Aleid ⁷, Abduljaleel Alalwan ⁵, Abdulrahman Aljumah ⁵, Thamer Aldarsouny ⁸, Faisal A Batwa ¹, Jawad Basubiah ⁹, Haziz Albiladi ³, Ayman A Abdo ², Hamad Al-Ashgar ⁴

Background: Chronic hepatitis C virus (HCV) infection in patients with stage 4–5 chronic kidney disease increases the risk of death and is prevalent in about 13% of patients undergoing hemodialysis in Saudi Arabia. Limited real-world data has shown high efficacy of co-formulated ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in genotype (GT) 4-infected patients with stage 4-5 chronic kidney disease (CKD). We examined the efficacy and safety of OBV/PTV/r, given with or without ribavirin (RBV) in treatment-naïve and interferon (IFN) experienced CKD patients.

Methods: In this ongoing multicenter phase 3b, randomized, open-label trial, eligible participants were recruited from five centers in Saudi Arabia. Participants were non-cirrhotic, with stage 4-5 CKD, with chronic HCV GT4 infection (documented ≥6 months before screening) and HCV RNA levels higher than 1,000 IU/mL. Treatment-naive patients were randomly assigned (1:1) by computer-generated randomization lists to receive once-daily OBV/PTV/r with or without RBV 200 mg for 12 weeks. All previous IFN-treated patients received the RBV-containing regimen. The primary endpoint was a sustained virologic response (HCV RNA <15 IU/mL) 12 weeks after the end of treatment (SVR12). Analysis was by intention to treat (ITT) as well as a modified ITT (mITT) analysis for patients who had completed at least 12 weeks of post treatment follow-up. This study is registered with sfda.gov.sa, number SCTR17021402.

Results: Overall, 28 patients were treatment-naive, of whom 15 received OBV/PTV/r and 13 received OBV/PTV/r with RBV, and 15 were treatment-experienced who received the RBV-containing regimen, and all were hemodialysis dependent. Of the 43 patients who received at least one dose of study medication, six were excluded from the primary efficacy analysis for non-virological reasons (death [n=5], patient withdrawal [n=1]). The interim mITT analysis revealed no virologic failures in the three treatment arms, with SVR4 (n=38) and SVR12 (n=31) rates of 100% each. Virologic efficacy was high regardless of GT4 subtype (4a=26, 4d=9, others=8). On an ITT analysis, in treatment-naive patients, SVR12 rates were 71.4% (10/14) in the RBV-free and 90·9% (10/11) in the RBV-containing regimen. In treatment-experienced patients SVR12 was 91.7% (11/12). Six patients (11.6%) had serious adverse events leading to treatment failure, including 5 deaths (3 on-treatment deaths [2 sepsis-related, 1 with cardiac arrest], and 2 post-treatment deaths [cerebral ischemia-related] 8 weeks after completing therapy) and none were considered treatment-related; 1 patient withdrew from the study due to on-treatment ileus. Dose interruptions of study medications, including RBV, were noted in 7 (16.3%), predominantly in the RBV-containing arms (5/28, 17.9%) for hemoglobin less than 100 g/L.

Conclusion: Treatment with the OBV/PTV/r regimen is effective in GT4 non-cirrhotic patients with stage 4-5 CKD, achieving high SVR12 rate. RBV use impacted on-treatment adherence rate resulting in frequent dose interruptions but did not impact virologic efficacy.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/60: GREATER PREVALENCE OF COMORBIDITIES WITH INCREASING AGE: CROSS-SECTIONAL ANALYSIS OF CHRONIC HEPATITIS B PATIENTS IN SAUDI ARABIA

Faisal M Sanai ¹, Hamdan Alghamdi ^2,³, Khalid A Alswat ⁴, Mohammed A Babatin ⁵, Mona H Ismail ⁶, Waleed K Alhamoudi ⁴, Abduljaleel M Alalwan ^2,³, Yaser Dahlan ^1,³, Abdullah S Alghamdi ⁵, Faleh Z Alfaleh ⁴, Abdulrahman A Aljumah ^2,³, Ibrahim H Altraif ^2,³, Khalid Albeladi ^1,³, Faisal Batwa ^1,³, Waleed Alshumrani ^1,³, Drifa Belhadi ⁷, Victor Genestier ⁷, Ayman A Abdo ⁴

Background: Limited evidence is available on the age, prevalence of comorbidities and treatment pattern in patients with chronic hepatitis B (CHB) in Saudi Arabia. Our aim was to compare and characterize CHB patients in 2015 and CHB patients in 2010 and 2012.

Methods: We conducted and compared three cross-sectional analyses of CHB patients ≥ 18 years of age with CHB defined as either positive HBsAg or HBV DNA or HBeAg or a documented history of CHB in 2010, 2012 and 2015. We used the multicentre SOLID database provided by the Liver Disease Research Center of the King Saud University Medical City.

Results: We identified a total of 765 CHB patients: 274, 256 and 235 in 2010, 2012 and 2015 respectively. The median age was significantly higher in 2015 (47 years) compared with 2010 and 2012 (41 and 42 years, respectively). There are significantly more CHB patients with an advanced liver disease, such as cirrhosis and hepatocellular carcinoma (HCC), in 2015 compared to 2010 and 2012 [p<0.05; cf. Figure 1]. Specifically, the proportion of patients with HCC ranged from 1% to 12% between 2010 and 2015 and the proportion of patients with cirrhosis ranged from 5% to 23% between these two years. Additionally, a higher number of patients with other comorbidities in 2015 was also identified compared to 2010/2012. Significantly more patients were associated with a coronary artery disease in 2015 compared with 2010 (10% vs. 4%); with hyperbilirubinemia (9% vs. 18%); and with hepatic steatosis (25% vs. 32%). There is also a numerical, although non-significant, difference in terms of proportion of patients with diabetes (25% in 2015 compared to 19% in 2012 and 22% in 2010). The proportion of patients who previously received a treatment for CHB was also significantly higher in 2015 compared with 2010/2012 [22% vs. 7%/5%; cf. Figure 2]. This difference is mostly driven by the proportion of patients who received lamivudine as a previous treatment (from 3% in 2010 to 8% in 2015). Additionally, the rate of patient “currently” receiving a treatment (at the year of assessment, i.e. 2010, 2012 or 2015) was also significantly higher in 2015 (56%) compared with 2010 (18%) and 2012 (16%).

Proportion of patients with advanced liver diseases and other comorbidities

Conclusions: Between 2010 and 2015, the CHB population in Saudi Arabia was significantly ageing and patients were more likely to develop advanced liver diseases such as cirrhosis and HCC or other comorbidities such as coronary artery disease. Those results are consistent with a previous longitudinal analysis (2006-2015) conducted on U.S. CHB patients which reported an increasing age and an increasing prevalence of associated comorbidities.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/61: A COST-EFFECTIVE APPROACH TO REDUCING DISEASE OUTCOMES OF HEPATITIS B VIRUS INFECTIONS: A MODELING ANALYSIS IN THE SAUDI POPULATION

Faisal M Sanai ¹, Abduljaleel Alalwan ¹, Waleed Al-Hamoudi ^2,³, Faisal Abaalkhail ², Naser Almasri ⁴, Faleh Z Alfaleh ³, Devin Razavi-Shearer ⁵, Homie Razavi ⁵, Jonathan Schmelzer ⁵, Mohammed Alghamdi ⁶

Background: No virological cure exists for hepatitis B virus (HBV) infection, and existing therapies are designed to control viral replication. We aimed to estimate the national prevalence of HBsAg in 2017 and study the impact of enhanced diagnosis rate and universal treatment administration on HBV-related outcomes in Saudi Arabia.

Methods: A dynamic transmission and disease burden model was developed to estimate the future economic burden of HBV infection. The infected population was tracked by age-and gender-defined cohorts, and direct costs (healthcare, screening, diagnostics and treatment) and indirect costs (disability-adjusted life years and the value of a statistical life year) were calculated. The impact of two intervention scenarios (A: Diagnose 90% of infections and treat 80% of high viral load patients by 2030; and B: diagnose and treat all patients by 2022) were compared against the base scenario (no policy action), with near universal vaccination coverage rates held constant, and a sensitivity analysis of future treatment cost was conducted.

Results: In 2017, the CHB prevalence was estimated at 1.6% corresponding to 536,000 infections. The same year, there was an estimated incidence of 760 cases of decompensated cirrhosis, 1,700 cases of hepatocellular carcinoma (HCC) and 2,200 liver-related deaths (LRD). CHB prevalence was 0.1% among 5 year olds and <.03% among infants. Disease burden outcomes by 2030, as compared with 2015, were as follows - Base: LRDs and HCC incidence were projected to increase by 40% and 60%, respectively. Intervention A: 40% decline in both HCC incidence and LRDs. Intervention B: >95% decline in HCC incidence and 90% decline in LRDs. In all scenarios, CHB prevalence among infants and 5 year olds declined to <.02%. Direct costs increase and peak by 2022 in both intervention scenarios due to expansion of treatment and diagnostics. However, these are offset by indirect cost savings starting immediately in Intervention A and by 2023 in Intervention B. Intervention A is estimated to achieve a positive return on investment (ROI) by 2021 at a treatment price of SAR 10,000 ($2667) yearly. Intervention B, however, would require a 90% reduction in unit cost of treatment to achieve a positive ROI by 2030.

Conclusions: Increased diagnosis and treatment rate of HBV would lead to significant declines in HCC and LRDs. This effect would be dramatically enhanced by administering treatment to all HBV cases regardless of viral load, and estimated to be cost-effective if treatment costs can be substantially reduced.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/62: EFFECTIVE HEMOSTASIS BY SPRAYING CYANOACRYLATE GLUE ON DIFFICULT-TO-CONTROL BLEEDING DUODENAL ULCER

Omar Alnabihi ¹, Faisal Batwa ¹, Waleed Alshumrani ¹, Faisal M Sanai ¹

Case Presentation: The endoscopic management of upper gastrointestinal bleeding can be done with a number of different endoscopic techniques. However, a small number of patients have persistent bleeding requiring radiological or surgical intervention. Herein, we present a case of massive duodenal ulcer bleeding that was managed by spraying cyanoacrylate glue on the duodenal ulcer after failure of multiple modalities. A 44-year old female with multiple comorbidities including metastatic breast cancer presented with malena. She was not using any anti-steroidal or anticoagulant medications. At admission, the heart rate was 132 beats/min, supine blood pressure of 81/52 mmHg, and FiO₂ of 99%. An esophagogastroduodenoscopy (EGD) revealed an actively bleeding duodenal ulcer, managed with injection of 10 ml of epinephrine (1:10,000) and by applying three endoclips. She was maintained on proton pump inhibitor infusion. However, the bleeding recurred within 24 hours, with hemodynamic instability, bright red blood in the naso-gastric tube and reduction in the Hb. A repeat EGD revealed active bleeding from the ulcer. Argon plasma coagulation was applied repeatedly on the ulcer area that failed to control the profuse bleeding. Subsequently, cyanoacrylate (Histoacryl^®) was sprayed on to the ulcer surface that achieved immediate hemostasis. No further bleeding occurred and the patient was discharged from the hospital after 7 days. This case demonstrates the potential efficacy of cyanoacrylate glue spray on the ulcer surface for hemostasis in patients with difficult-to-control bleeding failing conventional endoscopic therapies. Prospective studies with a larger number of patients are required to evaluate the role of the cyanoacrylate spray technique for ulcer bleeding.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/64: ACUTE REVERSIBLE RHABDOMYOLYSIS DURING IN PATIENT WITH CHRONIC HCV INFECTION WHO RECEIVED DIRECT ACTING ANTIVIRAL THERAPY: A CASE REPORT

Abdulrahman Y Qatomah ¹, Majidah Bukhari ¹, Edward Cupler ¹, Mohammad Mawardi ¹

Background: Hepatitis C virus infection is one of the most common causes of chronic liver disease worldwide. Therapy of hepatitis C Infection (HCV) has dramatically improved over the past few decade with introduction of direct-acting antiviral agents (DAAs). In the Era of new direct acting antiviral therapy, with a rate of sustained virological response that can be achieved in more than 90% of the cases with fewer adverse events and higher tolerability than previous conventional therapy with interferon based regimens. Rhabdomyolysis is a syndrome caused by injury to skeletal muscles. It involves spillage of large quantitation of toxic contents into plasma including myoglobin which precipitates in the glomerular filtrate resulting in tubular obstruction and direct nephrotoxicity. Rhabdomyolysis is an adverse event that occurs with DAA use mainly due to drug-drug interactions with concomitant use of HMG-COA Reductase inhibitors (statins), and other myotoxic agents. Rhabdomyolysis can develop in patients diagnosed with very long-chain acyl-coenzyme A dehydrogenase (VLCAD) deficiency. VLCAD disease is an autosomal recessive mitochondrial fatty acid oxidation disorder that is associated recurrent rhabdomyolysis. L-Carintine is considered therapeutic option which minimizes the chance of recurrent rhabdomyolysis. Affected patients are typically placed on a low-fat and high carbohydrate diet.

Case presentation: We report a rare case of reversible rhabdomyolysis in a 31 year-old male patient with VLCAD and chronic hepatitis C infection. Upon presentation to the Hepatology clinic, the patient was on L-Carnitine supplements and denied history suggestive of decompensation of liver disease. Patient received interferon based regimen previously and stopped due to the development of acute rhabdomyolysis. His investigations showed HCV PCR RNA 182624 IU/ml, with genotype 4, ALT 51 u/l, AST 30 u/l, alkaline phosphatase 85, Total Bilirubin 9 umol/L, PT 11.2 second, PTT 30.8 second, INR 1.0 and creatine kinase 546. Liver biopsy showed periportal inflammation consistent with chronic HCV infection grade 1 stage 0 fibrosis. The patient received new direct-acting antiviral agents with combination of sofosbuvir and daclatasvir. Planned to complete total duration of 12 weeks. Two weeks later, the patient underwent blood work which showed elevated level of creatinine kinase of 2572 IU/L. He was treated conservatively and DAAs were discontinued. There were no other precipitating factors. Patient was compliant to L-Carnitine intake. His repeated creatinine kinase level normalized few days after.

Conclusion: This case highlights possible association between DAA and rhabdomyolysis in patients with VLCAD. Up to our knowledge this is the first case in the literature to be reported. Further studies are needed to assess possible impact and association of such interactions.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/65: DO ALL ASIAN INFLAMMATORY BOWEL DISEASE PATIENTS SHARE SIMILAR PHENOTYPIC CHARACTERISTICS? TRANSETHNIC ANALYSIS OF 6,158 SUBJECTS

Chung Yau Nah ¹, Wee Khoon Ng ¹, Whitney Tang ¹, Rupa Bannerjee ², Raja Affendi Raja Ali ³, Shanthi Palaniappan ³, Majid A Almadi ⁴, Othman R Alharbi ⁴, Nahla Azzam ⁴, Abdulrahman M Aljebreen ⁴, Siew C Ng ¹

Background: Incidence of inflammatory bowel disease (IBD) is increasing rapidly in Asia. We aimed to investigate phenotypic characteristics across different Asian ethnicities and geography for Crohn’s Disease (CD) and ulcerative colitis (UC).

Methodology: Retrospective analysis of medical records of IBD patients from four different IBD registries in Hong Kong, Malaysia, India and Saudi Arabia were reviewed. Demographics were analysed according to four respective ethnicities: Chinese (C), Indian (I), Malay (M) and Arab (A).

Results: A total of 6,158 patients with IBD were included. Arabs had the youngest age at diagnosis for CD and UC compared with other ethnicities [median age in years (interquartile range)]: Arabs vs. Chinese vs. Indians vs. Malays; for CD 22 (12) vs. 30 (21) vs. 30 (17) vs. 26 (17); and for UC 28 (16) vs. 42 (21) vs. 35 (18) vs. 38 (26). There is a higher prevalence of UC (59-67%) compared to CD amongst the Chinese, Indians and Malays whereas CD was more common in the Arabs [Table 1]. Amongst patients with CD, Arabs (32%) had the highest prevalence of perianal involvement at diagnosis followed by Chinese (23%), whereas only 8% of Indians and Malays presented with perianal disease. The most common phenotype at first presentation for CD was non-stricturing and non-penetrating disease for the Chinese, Malays and Arabs whereas more than half the Indian subjects presented with stricturing phenotype. In patients with UC, majority of Chinese, Malay and Arab patients had pancolitis while majority of Indian patients had left sided colitis.

Table 1.

Patient characteristics of inflammatory bowel disease in different ethnicitiesa

Ethnicity	Chinese		Indian		Malay		Arab
Ethnicity
CD/UC	CD	UC	CD	UC	CD	UC	CD	UC
n (%)	1047 (39.5)	1601 (60.5)	887 (41.3)	1260 (58.7)	72 (33.2)	145 (66.8)	644 (56.2)	502 (43.8)
Median age at diagnosis (years), (interquartile range)	30 (21)	42 (21)	30 (17)	35 (18)	26 (17)	38 (26)	22 (12)	28 (16)
Sex (male to female, proportion)	1.90	1.26	1.44	1.50	1.12	1.84	1.30	0.95
Smoking^a (proportion)	4.20	3.64	14.3	11.7	2.79	3.14	6.32	16.3
Familial aggregation (%)	2.58	2.50	4.62	5.40	0	0.69	8.23	6.37
Perianal involvement, CD (%)	23.2	-	8.57	-	8.33	-	31.8	-
Most common phenotype
At presentation, CD - nonstricturing, nonpenetrating (%)	63.6	-	30.8	-	70.8	-	48.1	-
Worst ever, pancolitis, UC (%)	-	34.3	-	29.7	-	46.2	-	41.8

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^aHistory of smoking to no history of smoking. CD: Crohn’s disease, UC: Ulcerative colitis

Conclusion: Significant variations in phenotypic expression of IBD exist between different Asian ethnicities.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/66: ENDOSCOPIC CLIPPING FOR THE TREATMENT OF SLEEVE GASTRECTOMY LEAKS: IT WORKS!

Bader Shirah ¹, Ali Almontashery ¹, Khalid Alshahrani ¹, Adel Bakhsh ¹, Yaser Dahlan ¹

Background: Laparoscopic sleeve gastrectomy (LSG) has gained increased popularity as a primary weight loss procedure in the past 10 years. The most dreaded complication of LSG is a leak, reported in 1–7% of patients. This complication can be difficult to manage and there is little published data and agreement between experts on approaching it. The purpose of this study is to present our experience in the management of a persistent staple line leak post LSG using endoscopic clipping for selected patients.

Methods: Twelve patients presented to King Abdulaziz Medical City -Jeddah with clinical and radiological evidence of a leak post LSG were reviewed. All patients underwent a diagnostic exploration with over-sewing of the staple line, wide local drainage, and insertion of a feeding jejunostomy tube. Two weeks post operatively, upper GI studies showed a persistent leak at the esophagogastric junction, upper GI endoscopy was then used to obliterate the orifice using several endoclips in four patients who were selected based on small leak <1 cm and no intra-abdominal collection.

Results: This approach achieved adequate control of the leak in 3 patients and failed in one patient due to anatomical difficulties. After negative radiological studies, oral diet was commenced 7 days post clipping and the patients were successfully discharged home.

Conclusion: Adopting a standard approach for management of sleeve gastrectomy leaks is warranted. Early diagnosis and exploration with sepsis control and nutritional support are the cornerstones of this approach. Endoscopic clipping is a safe and a feasible therapeutic option in the treatment of staple line leaks post LSG especially for small leaks. Its value compared to the other treatment options for refractory leaks needs to be evaluated in a prospective comparative study.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/67: METRIC-BASED TRAINING TO PROFICIENCY SIMULATION CURRICULUM FOR BASIC ENDOSCOPY: VIRTUAL REALITY ENDOSCOPY CURRICULUM IMPROVES PERFORMANCE ON THE FUNDAMENTALS OF ENDOSCOPY TRAINING

Nahla Azzam ¹, Majid Almadi ^1,², Faisal Batwa ³, Fahad Alsohaibani ⁴, Abdulrahman Aljebreen ¹, Ahmad Alharbi ³, Yasser Alaska ⁵, Tuki Alameel ⁶, Nehal Alkhamis ⁵

Background: The demonstration of competency in upper GI endoscopy prior starting Saudi Gastroenterology fellowship program is required. To demonstrate competency, the novice fellows must get over a simulation course. The purpose of this study was to design a proficiency-based virtual reality (VR) endoscopy simulation curriculum to meet this competency requirement.

Methods: This is a prospective cohort study at a single academic medical institution. Prior to patients encounter the GI fellows were required to participate in a simulation course and demonstrate proficiency on technical simulation tasks. Proficiency was determined based on six VR module tasks that includes: total procedure time, number of attempt of esophageal intubation, scope navigation, mucosal inspection, amount of air left in the stomach, and percent of discomfort. 5 experienced (GI consultants with minimum of 5 years experience) and 10 inexperienced endoscopists (the novice GI fellows with no prior exposure to endoscopy or simulator) were recruited to participate. Inexperienced endoscopists completed train-to-proficiency faculty-supervised simulation tasks. All participants were asked to perform the selected upper GI modules twice, and median performance was compared between the two groups.

Results: Construct valid metrics were identified for six modules and proficiency benchmarks were set at the median performance of experienced endoscopists. Inexperienced endoscopists had significantly higher median total procedure time and time to pylorus time (12.6 ± 3.2 & 7.8 ± 2.8, p = 0.000) minutes versus experienced endoscopists (3.7 ± 0.9 & 1.8 ± 1.4, p = 0.000) however the novices had a lower amount of air left in the stomach compared to experienced endoscopists (68.1 ± 23 vs 94 ± 7.8 cc, p = 0.001) respectively. The median overall trials to proficiency in all tasks were 3 (IQR: 2-6). There was no difference between prior endoscopic experience and the novice trained to proficiency on other VR module tasks. Reported confidence in endoscopic skills was increased significantly from mean of 2.75 prior to 7.86 following the simulation course (p=0.002). All of the fellows passed the assessment test at the end of the course.

Conclusions: In this study, a train-to-proficiency curriculum improved the performance in upper endoscopy skills among the novice GI fellows. Our findings also indicate that proficiency can be achieved by using a well-structured VR simulation curriculum.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/68: THE OUTCOMES OF FULLY COVERED STENT IN THE TREATMENT OF LEAK AND STRICTURE AFTER GASTRIC SLEEVE SURGERY

Emad Aljahdali ¹, Ammar Aldabbagh ¹, Fatma Salah ¹, Ashraf Maghrabi ¹, Mahmoud Mosli ¹

Background: As diet patterns have become westernized in Saudi Arabia, simultaneously with a sedentary lifestyle; the prevalence of obesity has rapidly grown. Bariatric surgeries, such as Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are considered the first-line treatment option in patients with severe obesity. SG has been increasingly performed due to its simplicity. Despite advances in surgical techniques, some still develop postoperative complications. Postoperative complications include bleeding, strictures, suture line leaks and fistulae. Endoscopic evaluation is often required for diagnosis and management given high risk related to surgical reintervention. Various studies had evaluated the use of partially covered and fully-covered self-expandable metallic stents (SEMSs) in the management of SG complications. In this study, we aim to assess the use of fully-covered SEMSs in the management of post SG leak and stricture. The study also looks at the optimal stent duration required for managing such complications.

Methods: This study is a retrospective chart review of all patients who developed post SG leak or stricture and referred for endoscopic management using FC-SEMS. The study was conducted at King Abdulaziz University Hospital (KAUH) in Jeddah, Saudi Arabia, between September 2017 to November 2018. Patients were either done at or referred to KAUH from other hospitals. The following demographic characteristics were obtained from hospital records: age, gender, type of post SG complication (leak or stricture); type of stent placed; total days post surgery before insertion; presence of post insertion pain, nausea or vomiting; site where distal end of the stent was placed; total weeks before stent removal; stent migration; early removal (before six weeks); stent-related complications; need for stent re-insertion or surgery, and outcome. The diagnosis of both leak and stricture was made by either contrast imaging study or upper endoscopy evaluation or both.

Results: A total of 11 patients were enrolled in the study. The mean age of patients was 44.54 years and median was 44 (range 32-66) including 45.45% men and 54.55% women. Of the 11 patients; 7 (63.6%) sustained SG leak and 4 (36.3%) had SG stricture. All patients were treated with FC-SEMS. In 72.2% the distal end of the stent was placed in the pre-pyloric region and 27.2% were placed in the duodenum. The mean duration between the SG and stent insertion was 28.9 days (ranging from 4 to 112 days). The size of used stents ranged from 22 mm to 28 mm in diameter and 15 mm to 240 mm in length. Vomiting was the most common complication post-stent insertion and was reported in 81.8% of cases, while post insertion pain and nausea was 54.5% and 72.7%, respectively. The mean duration between stent insertion and removal was five weeks (rage 2-16 weeks). Additional details regarding the association between duration of stent placement and complications are explained in Table 1. Stent migration was reported in 3 patients (27.2%). Early stent removal was required in one patient only due to persistent nausea and pain. This patient had the stent initially placed for surgical sleeve redo leak. Complications of the stent insertion were as follow: two patients (18.1%) developed esophageal stricture and one patient (9%) had bleeding, while eight patients (72.7%) had experienced no stent-related complications. None of the patients required stent re-insertion. Technical success was achieved in all patients. Clinical success (complete resolution of leak and stricture) was reported in 9 patients (81.8%). Only one patient (18.1%) underwent surgical intervention for an unrelated indication which is arterial duodenal ulcer bleeding. Two patients developed stent-induced esophageal stricture. Both had the stent placed for over six weeks.

Table 1.

Duration of stent placement and their outcomes

Duration of stent placement (weeks)	n (%)	Complications (%)
<6	7 (63.6)	0
>6	4 (36.3)	75

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Conclusion: Laparoscopic SG is gaining popularity in treating morbid obesity, with relatively acceptable complication rates. Endoscopists must be familiar with bariatric surgery-related complications and the feasibility and safety of endoscopic approach to successfully manage them. Endoscopic placement of FC-SEMSs is considered safe and minimally invasive option for the management of post SG leak and stricture. Vomiting was the most common complication after stent insertion. A small number of patients had stent migration, bleeding or stent-induced esophageal stricture. In our study, the duration of stent placement for more than six weeks could be associated with the risk of developing esophageal stricture. Further studies with a larger population are needed to assess this hypothesis.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/69: HCV RNA IN LIVER TISSUE AFTER SUSTAINED VIROLOGIC RESPONSE IN PATIENTS TREATED WITH DIRECT ACTING ANTI-VIRAL AGENTS

Musthafa Peedikayil ¹, Hamad Al Ashgar ¹, Hussa Alhussaini ¹, Mohammed Al Quaiz ¹, Khalid Al Kahtani ¹, Amr Maged Elssadany ², Ahmed AlQahtani ³

Background: Persistence of Hepatitis C Virus RNA in the liver tissue has been reported after sustained virologic response (SVR) in patients treated with pegylated interferon and ribavirin. However, HCV RNA’s existence in the liver tissue has not been studied in patients treated with direct acting anti-viral agents (DAA) and achieved SVR 24 weeks. This study aimed to test a hypothesis that HCV RNA might survive in the liver tissue and/or in the peripheral blood mononuclear cells despite undetectable HCV RNA by PCR tests in the blood after SVR 24 weeks.

Methods: We prospectively selected chronic hepatitis C patients who achieved SVR 24 weeks after treatment with direct acting anti-viral agents. Blood samples of these patients were collected, and liver tissue was obtained. HCV RNA detection was done in three stages. In the first stage, blood and liver tissue RNA and DNA was co-purified using DNeasy Blood & Tissue Kit (Qiagen GmbH, Germany) [Figure 1]. In the second stage, reverse transcription polymerase chain reaction was conducted by using superscript (IV Invitrogen) first strand synthesis system and generated cDNA. In the final stage, quantitative and qualitative detection of HCV RNA PCR amplification was done using the primers for 5’ untranslated region (5’UTR), and a product of 241 bp was formed representing the HCV RNA.

HCV RNA of five patients in the liver tissue were negative by Reverse transription polymerase chain reactio. Thick white line is from control-patient with HCV RNA positive control in the liver tissue

Results: A total of eleven patients were recruited but four of them withdrawn from the study. Six patients peripheral blood mononuclear cells and five patient’s liver tissue was tested for HCV RNA by reverse transcription method. HCV RNA was not detected from none of the patients’ peripheral blood mononuclear cells and liver tissue by using reverse transcription method [Figure 2]. This experiment proved that the virus from the liver tissue disappeared in patients with SVR.

HCV RNA in the peipheral blood monocuclear cells of all six patients were negative by reverse transription polymerase chain reaction. Thick white line represents control-patient with postive HCV RNA

Conclusion: Based on our experiment, we propose that HCV RNA disappears from the liver once these patients have sustained virologic response.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/70: BRIDGING WITH SPATZ3 INTRAGASTRIC BALLOON ON THE OUTCOME OF DEFINITIVE SLEEVE GASTRECTOMY IN SUPER-OBESE: A SINGLE CENTER EXPERIENCE

Mohammed Khan ¹, Adnan Al-Zanbagi ¹, Abdulaziz Tashkandi ¹, Abdulwahab Neyazi ¹, Laeeque Ahmed ¹, M K Shariff ¹, Ali Montashery ¹

Introduction: Super Obesity (BMI >60 kg/m²) is an independent risk factor both for anesthetic and laparoscopic bariatric surgical outcomes. Such patients pose technical difficulties and increase the surgical complications. Preoperative weight loss may help to reduce this increased risk. Intragastric balloon placement has shown mixed results of weight reduction in this population.

Aim: To determine the effect of preoperative insertion of SIG on the definitive outcome of Laparoscopic Sleeve Gastrectomy (LSG).

Methods: Super obese patients who had SIG inserted with a view to definitive LSG and had 6 months follow up were retrospectively analyzed.

Results: 41 patients had SIG inserted with a mean (±SD) age, initial BMI and weight of 40.9 years (± 11.16), 71.69 kg/m² (± 7.48) and 189.64 kgs (± 28.55), respectively. 4 were lost to follow up and 2 had SIG removed within 2 weeks due to intolerance. The average weight loss was 17.49 kgs with average BMI reduction of 7.11 kg/m² and 14.51% of excess body weight loss. 18/35 (51%) underwent definitive LSG. Median length of hospital stay post LSG was 3.6 (range 4 – 5) days, with no major complications or readmissions. 5 patients are awaiting LSG.

Conclusion: In this cohort of super obese SIM offered an effective means of pre-operative weight loss with more than 50% ultimately having a definitive LSG without major complications and an uneventful post-operative period.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/71: THE ROLE OF ENDOSCOPIC HEMOSTATIC POWDER IN NON-VARICEAL GASTROINTESTINAL BLEEDING: A SYSTEMATIC REVIEW AND META-ANALYSIS WITH IMPLICATION ON CLINICAL PRACTICE

Majidah A Bukhari ^1,², Mohannad A Aljehani ¹, Mohamad H El Zein ³, Abdulrahman Qatomah ¹, Yamile Haito-Chavez ⁴, Waad A Sabbagh ¹, Asma A Alkandari ⁵, Abdullah Alkhattabi ¹, Haneen Y Alomar ¹, Mostafa Ibrahim ^6,⁷, Mouen A Khashab ²

Background: Acute non-variceal upper gastrointestinal bleeding (NVUGIB) is a common medical problem that results in high morbidity and mortality. Endoscopic hemostasis has been widely accepted as first-line management for patients with NVUGIB. Hemostatic nanopowder is a novel therapy used to treat patients with upper gastrointestinal bleeding. Hemostasis is achieved by adhering of the powder to the bleeding site, which leads to a mechanical barrier. The powder has been shown to enhance clot formation and shortens coagulation time. It is delivered through a catheter and sprayed onto the bleeding site under direct endoscopic guidance, without direct tissue contact. The reported success rate of homeostatic nanopowder in patients with NVUGIB ranges between 75 to 100%, with the re-bleeding rate of 10-49%. This systematic review and meta-analysis aimed to assess the effectiveness of hemostatic powder in achieving initial hemostasis, either as primary monotherapy, or as a part of salvage therapy in treating patients with NVUGIB.

Methods: We performed a comprehensive literature search of PubMed, EMBASE, Web of Science, and Cochrane Library through November 2018. Studies with more than ten patients were selected according to predefined criteria and analyzed to generate pooled data. Weighted pooled rate (WPR) for initial hemostasis, rebleeding rate for primary monotherapy or salvage therapy, and post-procedure complications were calculated for overall studies. Heterogeneity was quantified using the I-squared measure. Meta-analysis with Fixed effects model was performed to calculate data for initial hemostasis, rebleeding rate, and complications.

Results: Out of 1379 studies obtained from the initial database search, 16 studies with a total of 688 patients met the inclusion criteria and were included in the meta-analysis. Most of the patients were treated for peptic ulcer bleeding (62.5%). Hemostatic powder was used in 473 (68.8%) patients as primary monotherapy and in 215 (31.2%) patients as a salvage therapy. The weight pooled rate (WPR) for initial hemostasis as primary monotherapy was 93% (95% CI: 0.93-0.90) and 95% (95% CI: 0.91-0.97) as a salvage therapy [Figures 1 and 2]. The rate of rebleeding after initial hemostasis in monotherapy was 19% (95% CI: 0.16-0.23) and salvage therapy was 31% (95% CI: 0.25-0.13) respectively [Figures 3 and 4]. The WPR for post-procedure complications was 4% (95% CI: 0.02-0.07).

Forest plot for initial hemostasis as primary monotherapy

Forest plot for initial hemostasis as salvage therapy

Forest plot for rebleeding in the primary monotherapy

Forest plot for rebleeding rate in salvage therapy

Conclusion: Hemostatic nanopowder appears to be a safe and effective therapeutic option for the management of acute non-variceal upper gastrointestinal bleeding. This study represents the first meta-analysis that demonstrates the success of the hemostatic nanopowder in those patients. Further trials should clarify the ideal setting for the use of hemostatic powder.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/72: PREDICTORS OF COMPLICATIONS AND WEIGHT LOSS FOLLOWING INTRAGASTRIC BALLOON INSERTION

Adnan Al-Zanbagi ¹, Abdulaziz Tashkandi ¹, Mohammed Khan ¹, Ishtiaq Ahmed ¹, Mahmoud H Eliouny ¹, Zaffar M Malik ¹, Mohamed Hefny ¹, M K Shariff ¹

Background: Obesity is a major global health issue and to address this multiple weight reduction strategies are emerging. Intragastric balloon (IGB) insertion has shown to be an effective option. However, it is associated with adverse events and the weight loss is variable. Hence, the aim of this study is to identify factors associated with weight loss and complication following insertion of IGB.

Methods: Retrospective analysis of the complications and weight loss of the patients who had IGB inserted at King Abdullah Medical City, Makkah, a tertiary referral center for Bariatric surgery.

Results: Of the 72 patients who had IGB inserted 24 (66.7%) developed an adverse event, including 5 early removals within 2 weeks. In multivariate stepwise backward logistic regression female gender was identified as the only predictor of adverse event (P=0.009; odds ratio 0.247 95% confidence interval 0.086 – 0.711). The most common complication was abdominal pain occurring in 15 patients (21%). Data at 6 months follow up was available in 67 patients with mean percentage of excess body weight loss of 17.47%±14.21% with a reduction of BMI of 6.33 kg/m². On a multiple regression model weight loss at 3 months and asthma were significantly correlated with the percentage of excess weight loss (P <0.001 and P = 0.04, respectively).

Conclusion: In this cohort, gender of the patients was associated with complications and weight loss at 3 months and asthma predicted the final weight loss.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/73: NUTRITIONAL RISK SCREENING AMONG HOSPITALIZED PATIENTS; APPLICATION AT A UNIVERSITY HOSPITAL IN SAUDI ARABIA

Adil A Alzahrani ¹, Ahmad A Alghamdi ¹, K M Almalki ¹, R O Alshati ¹, M M Jamjoom ¹, A B Zamka ¹, H O Bogari ¹, A K Aljarallah ¹, Hani A Jawa ¹

Background: Hospital malnutrition is prevalent worldwide and is associated with delayed patient recovery, increased infections, prolonged hospital stays and mortality. The nutritional risk screening 2002 (NRS-2002) is a well validate tool which identifies patients who could benefit from early nutrition support. We aimed to estimate the point prevalence of nutritional risk among hospitalized patients at an academic tertiary hospital in Saudi Arabia.

Patients and Methods: NRS-2002 screening was conducted on adult patients newly admitted to medical and surgical wards over a period of 6 weeks. Intensive care and pediatric patients were not included in this study. The “initial” component of screening [Table 1] was performed by trained senior medical students who then referred patients for the “final” screening component [Table 2] to be performed by the ward dietitian.

Table 1.

Initial screening

graphic file with name SJG-25-1-g010.jpg

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Table 2.

Final screening

graphic file with name SJG-25-1-g011.jpg

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Results: A total of 163 patients were screened (88 female and 75 male); average age was 52.3 years and mean body mass index (BMI) 29.9. Of the total patients receiving initial screening, 38.6% had their final screening recorded of whom 39.7% were found to be nutritionally at risk despite 80% of them not being underweight according to BMI criteria.

Conclusion: The use of validate nutritional screening tool on admission identified high risk patients who would have been missed by relying on BMI. Implantation of such tool into the hospital admission process may improve the nutritional care process and potentially improve outcomes.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/74: SIMILAR HEPATIC FIBROSIS IN CHRONIC HEPATITIS B E ANTIGEN-NEGATIVE PATIENTS WITH OR WITHOUT FLUCTUATING VIREMIA

Ahmad Alhouthali ¹, Hamdan Alghamdi ^1,², Feras Badriq ¹, Mohammed Mujalled ¹, Waleed Khayyat ¹, Motaz Attar ¹, Basil Bagadeem ¹, Alaa M Meer ³, Waleed Alshumrani ^2,³, Khalid Albeladi ³, Faisal A Batwa ^2,³, Faisal M Sanai ^3,⁴

Background: The accurate identification of inactive chronic hepatitis B virus (HBV) carriers from those with active carriers is difficult because of wide and frequent HBV DNA fluctuations. We aimed to assess if fluctuating HBV DNA levels impacted on the presence of significant hepatic fibrosis (Metavir F2-4) in HBeAg-negative chronic HBV patients.

Methodology: Untreated HBeAg-negative patients (n=175) with fluctuating HBV DNA above or below a level of 2000 IU/mL (n=50) were included and compared to those without fluctations (n=125). Patients without fluctuating HBV DNA were further analyzed on the basis of those with persistently low (<2000 IU/mL, n=103) and high HBV DNA (>2000 IU/mL, n=22). Hepatic fibrosis (transient elastography, FibroScan^®) was correlated with virologic and biochemical profiles of consecutive carriers.

Results: Mean age of the patients was 47.5 ± 12.5 years and 76 (43.4%) were male. HBV DNA fluctuations were frequent and occurred in 28.6% of the overall cohort. Patients with fluctuating viremia had higher log₁₀ qHBsAg (3.2 ± 0.8 vs. 2.8 ± 1.0, P=0.009) and HBV DNA (3.5 ± 0.4 vs. 2.8 ± 1.2, P<0.001) compared to those without fluctuations. Fluctuating viremia patients’ qHBsAg log₁₀ (3.2 ± 0.8) was also higher than those with persistently low (HBV DNA <2000 IU/mL) viremia level (2.6 ± 1.0, P=0.001). Patients with F2-4 were more likely to have higher BMI (P=0.033), AFP (P=0.012), AST (P<0.001) and ALT levels (P=0.021). Presence of F2-4 fibrosis in those with fluctuating HBV DNA was numerically lower (6%) but not significantly different from those without (15.2%, P=0.130), or from those with persistently low viremia (14.6%, P=0.193).

Conclusions: Fluctuating HBV DNA levels occur frequently but do not distinguish patients with higher prevalence of significant fibrosis. Minor fluctuations of HBV DNA levels are unlikely to be of clinical relevance. Patients with higher qHBsAg levels tend to have greater frequency of fluctuating viremia.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/75: TOFACITINIB FOR THE TREATMENT OF ULCERATIVE COLITIS: ANALYSIS OF INFECTION RATES FROM THE OCTAVE CLINICAL PROGRAMME

Kevin L Winthrop ¹, Edward V Loftus Jr ¹, Daniel C Baumgart ², Walter Reinisch ³, Andrew J Thorpe ⁴, Chudy I Nduaka ⁴, Nervin Lawendy ⁴, Gary Chan ⁴, Ronald D Pedersen ⁴, Chinyu Su ⁴

Background: Tofacitinib is an oral, small molecule Janus kinase inhibitor approved for the treatment of ulcerative colitis (UC). The safety of tofacitinib for treatment of moderate-to-severe UC was evaluated in 8-week induction Phase (P) 2/3 (NCT00787202; NCT01465763; NCT01458951) and 52-week maintenance P3 (NCT01458574) studies,[1] and an ongoing, open-label, long-term extension (OLE) study (NCT01470612).[2] We assessed infection incidence in the UC programme.

Methods: Patients receiving placebo, tofacitinib 5 or 10 mg twice daily were analysed as three cohorts: Induction (P2/P3), Maintenance (P3) and Overall (all P2/P3/OLE patients receiving tofacitinib; data cut-off: December 2016). Proportions and incidence rates (IRs; unique patients with events per 100 patient-years) were evaluated for infections of special interest.

Results: Tofacitinib exposure was 1612.8 patient-years (range 1–1606 days; median 514 days). Demographics were generally similar across treatment groups. Nasopharyngitis was the most frequent infection across cohorts. IRs for serious infection events (SIEs) were similar in Overall vs Maintenance Cohorts (all tofacitinib doses), with no apparent clustering of specific SIE types [Table 1]. In the Overall Cohort, 21 patients had opportunistic infections, most being non-serious herpes zoster mostly limited to skin involvement.

Table 1.

Demographics and summary of incidence of treatment-emergent infections (all causality) a in the induction, maintenance and overall cohorts

	Induction cohort (n=1220)		Maintenance cohort (n=592)			Overall cohort (n=1157)
						Overall cohort (n=1157)
	Placebo	Tofacitinib 10 mg BID	Placebo	Tofacitinib 5 mg BID	Tofacitinib 10 mg BID	Tofacitinib all
N (patient-years)	282 (44.8)	938 (156.2)	198 (100.4)	198 (146.2)	196 (154.3)	1157 (1612.8)
Demographics
Age (years), mean (SD)	41.4 (14.4)	41.3 (13.8)	43.4 (14.0)	41.9 (13.7)	43 (14.4)	41.3 (13.9)
Female, n (%)	127 (45.0)	381 (40.6)	82 (41.4)	95 (48.0)	86 (43.9)	478 (41.3)
Race
White, n (%)	229 (81.2)	756 (80.6)	155 (78.3)	164 (82.8)	153 (78.1)	927 (80.1)
Asian, n (%)	28 (9.9)	114 (12.2)	26 (13.1)	23 (11.6)	25 (12.8)	144 (12.4)
Disease duration (years), mean (SD)	8.2 (6.8)	8.2 (7.0)	8.8 (7.5)	8.3 (7.2)	8.7 (7.0)	8.2 (7.0)
AE, n (%), IR (95% CI)
AE (all)	155 (55.0)	515 (54.9)	149 (75.3)	143 (72.2)	156 (79.6)	950 (82.1)
Infection (all)^b	43 (15.2)	196 (20.9)	48 (24.2), 58.16 (42.88, 77.12)	71 (35.9), 62.54 (48.85, 78.89)	78 (39.8), 72.82 (57.56, 90.88)	572 (49.4), 60.34 (55.49, 65.49)
SIE^b,c	0 (0)	8 (0.9)	2 (1.0), 1.94 (0.23, 7.00)	2 (1.0), 1.35 (0.16, 4.87)	1 (0.5), 0.64 (0.02, 3.54)	33 (2.9), 1.99 (1.37, 2.79)
Opportunistic infection^b,c	0 (0)	3 (0.3)	1 (0.5), 0.97 (0.02, 5.42)	2 (1.0), 1.36 (0.16, 4.92)	4 (2.0), 2.60 (0.71, 6.65)	21 (1.9), ^d1.28 (0.79, 1.96)
Nonherpes-zoster opportunistic infection^b,c	0 (0)	1 (0.1)	0 (0), 0.00 (0.00, 3.57)	0 (0), 0.00 (0.00, 2.48)	0 (0), 0.00, (0.00, 2.35)	4 (0.4), 0.24 (0.07, 0.62)
Herpes zoster (all)^b	1 (0.4)	6 (0.6)	1 (0.5), 0.97 (0.02, 5.42)	3 (1.5), 2.05 (0.42, 6.00)	10 (5.1), 6.64 (3.19, 12.22)	65 (5.6), 4.07 (3.14, 5.19)

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^aOnly patients with events occurring within 28 days after the last dose are included in this table for calculation of proportion and IR, ^bData for the induction cohort are shown as n (%), due to the short duration (8 weeks) of the induction studies, ^cInfection endpoints are based on adjudicated data. Adjudicated events were based on review by an independent adjudication committee and calculated as percentages, based on the number of patients in the studies in which adjudication was performed, ^dOf the 21 patients with opportunistic infections in the overall cohort, 17 patients had herpes zoster which was non-serious and mostly limited to skin involvement (IR 1.04 [0.60, 1.66]; herpes zoster opportunisitic infections were classified as either multidermatomal [2 nonadjacent or 3-6 adjacent dermatomes] or disseminated [any of: diffuse rash >6 dermatomes, encephalitis, pneumonia, other non-skin organ involvement]), 1 patient had cytomegalovirus infection, 1 patient had histoplasmosis, 1 patient had cytomegalovirus hepatitis and 1 patient had pulmonary mycosis. AE: Adverse event, BID, twice daily, CI: Confidence interval; IR: Incidence rate (unique patients with events per 100 patient-years); N: Number of patients in the treatment group, n: Number of patients with a particular AE; SD: Standard deviation, SIE: Serious infection event

Conclusion: SIEs were infrequent. Herpes zoster was the most frequent OI; there was no evidence for increasing opportunistic infection risk with tofacitinib treatment duration. The safety profile generally appeared similar to that reported for rheumatoid arthritis[3] and other UC therapies.

REFERENCES

1.Sandborn WJ, Su C, Sands BE, D’Haens GR, Vermeire S, Schreiber S, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376:1723–36. doi: 10.1056/NEJMoa1606910. [DOI] [PubMed] [Google Scholar]
2.Lichtenstein, et al. Am J Gastroenterol. 2017:112. Abstract 714. [Google Scholar]
3.Cohen SB, Tanaka Y, Mariette X, Curtis JR, Lee EB, Nash P, et al. Long-term safety of tofacitinib for the treatment of rheumatoid arthritis up to 8.5 years: Integrated analysis of data from the global clinical trials. Ann Rheum Dis. 2017;76:1253–62. doi: 10.1136/annrheumdis-2016-210457. [DOI] [PMC free article] [PubMed] [Google Scholar]

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/76: A SYSTEMATIC REVIEW AND META-ANALYSIS OF THE EFFICACY OF MEDICAL TREATMENT FOR THE MANAGEMENT OF SOLITARY RECTAL ULCER SYNDROME

Yousef Qari ¹, Mahmoud Mosli ¹

Background: Solitary rectal ulcer syndrome (SRUS) is a benign condition with varying success rate of its tretament. There are no randomized controlled trials that have examined the long-term effectiveness of treatments and the aim of this study is to perform a systematic review and meta- anlysis of the medical literature to analye the efficay of medical treatment in SRUS.

Methods: Electronic databases like PubMed and Embase were searched to get both Randomized clinical trials and observational studies which evaluated medicaltreatment (sucralfate, sulfasalzine etc) in patients with SRUS. Two review authors independently performed data screening and data extraction. The primary outcome measure was proportion of patients who had ulcer remission from baseline to the follow up of the study and it was presented as pooled prevalence (PP) with 95% confidence interval (CI). I² value, Q statistic test were used to test Heterogeneity. Subgroup analysis was perofrmed to assess the sources of heterogenisity. If heterogeneity confirmed, a random-effects model was applied Otherwise, a fixed effects model was chosen. We also performed eggers test to asses the publication bias.

Results: A total of nine studies with 216 (males = 118, females = 98) patients diagnsoed with SRUS were analysied in final meta analysis. Among the included studies, five included adults subjects and three included only childrens. The pooled effect estimate (PP; 0.57; 95% CI; 0.41 to 0.73) from these nine studies revealed that of the patients recieving medical treatment, 57% had resolution of their ulcers.statisticaly significant heterogeneity (I² = 63% ; τ2 = 0.64, P = <0.01), hence the random effect model was choosen to pool the indiviudal studies. Subgroup analysis based on age revealed that pediatric patients had a higher proportion of ulcer resolution compared to adults. Publication bias was not observed (p = 0.03).

Conclusion: The majority of patients receiving medical treatment for the management of SRUS had resolution of their ulcers. There is a need for randomised clinical trials of SRUS medical treatment to further validate our findings.

Saudi J Gastroenterol. 2019 Mar;25(Suppl 1):S1–S39.

SJG2019/77: PREVALENCE AND CLINICAL PREDICTORS OF UPPER GASTROINESTINAL CROHN’S DISEASE

Mahmoud Mosli ¹, Kholoud Fallatah ¹, Abdulrhman Baradei ¹, Fatimah Howladar ¹, Motaz Daiwali ¹, Omar Alshuaibi ¹, Hani Jawa ¹, Emad Aljahdali ¹, Yousif Qari ¹, Omar Saada ¹

Background: Crohn’s’ disease (CD) can rarely involve any part of the gastrointestinal (GI) tract including the esophagus, stomach and duodenum. However, clinical features of upper GI Crohn’s (UGIC) are not clearly characterized. We therefore aimed calculate the prevalence and study clinical characteristics of patients diagnosed with UGIC.

Patients and Methods: We performed a retrospective analysis of all patients diagnosed with CD who underwent upper gastrointestinal endoscopy between 2012 and 2017 at King Abdul-Aziz University (KAU) hospital, irrespective of age. Patients with documented ulcerations involving the upper GI tract i.e. esophagus, stomach and duodenum seen endoscopically and confirmed histologically were labeled as UGIC. Data on demographics, disease characteristics, extra-intestinal manifestations, and symptomatology were reviewed. Frequencies and means were reported for categorical and continuous variables, respectively. Prevalence of UGIC was calculated and stepwise model selection was used to statistically identify clinical predictors.

Results: We identified 80 CD patients who underwent upper GI endoscopy from our medical records. Of the total, 5/80 (6.3%) had confirmed UGIC (1 esophageal, 3 gastric, and 1 duodenal). Mean age was 21 (+-9.4) years and 50% were males. Family history and ancestral consanguinity was reported in 7.5% and 41.3%, respectively. Disease distribution was ileo-colonic 38%, colonic 34%, and ileal in 20%. Non-stricturing non-penetrating phenotype was reported in 75%, stricturing in 15.4%, and fistulizing in 2.6%. 7.8% reported history of perianal disease. Extra-intestinal manifestations (EIMs) of CD were reported in 20% of patients. Model selection identified age (p=0.03) as the only significant predictor of UGIC.

Conclusions: The prevalence of UGIC is relatively low. Upper GI symptoms and malnutrition do not seem to predict the presence of UGIC.

[ref1] 1.Sandborn WJ, Ghosh S, Panes J, Vranic I, Su C, Rousell S, et al. Tofacitinib, an oral Janus kinase inhibitor, in active ulcerative colitis. N Engl J Med. 2012;367:616–24. doi: 10.1056/NEJMoa1112168. [DOI] [PubMed] [Google Scholar]

[ref2] 2.Sandborn WJ, Su C, Sands BE, D’Haens GR, Vermeire S, Schreiber S, et al. Tofacitinib as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2017;376:1723–36. doi: 10.1056/NEJMoa1606910. [DOI] [PubMed] [Google Scholar]

[ref3] 3.Lichtenstein, et al. Am J Gastroenterol. 2017;112 Abstract714. [Google Scholar]

PERMALINK

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