The Efficacy of Transnasal Esophagoscopy in Laryngopharyngeal Reflux Patients at HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC), Thailand

Abstract

To evaluate the positive pathological findings, patient satisfaction, pain, and complications of transnasal esophagoscopy (TNE) in laryngopharyngeal reflux (LPR) patients at HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC), Thailand. A descriptive cross-sectional study. Forty adult LPR patients who had failed 3-months proton-pump inhibitor therapy were recruited to undergo TNE at Otolaryngology department, MSMC from January 1, 2019 to December 31, 2019. Data including demographics, Reflux Finding Score, Reflux Symptom Index, Eating Assessment Tool (EAT-10) scores, and endoscopic findings were recorded and compared between patients who had positive pathological findings and those who had negative findings. Sixteen patients (40%) had positive findings, which led to the changes in management of their conditions. Most positive findings included multiple esophageal and gastric ulcers (4/16), gastric ulcer (3/16), esophagitis (2/16), and esophageal candidiasis (2/16). There was no statistically significant difference in the baseline data between patients in the TNE positive and the TNE negative groups. The average patient satisfaction on VAS was 8.60 ± 1.43. Most patients were in the mild pain score group (18/40). Complications were not encountered. TNE is an efficient tool for evaluating LPR in Thai patients. The procedure was proven to be safe, well tolerated, and highly satisfied.

Introduction

Gastroesophageal reflux disease (GERD) is a condition when refluxed stomach contents cause troublesome symptoms and/or complications in patients. This condition can be further divided into two categories, which are esophageal and extraesophageal syndromes [1]. Laryngopharyngeal reflux (LPR), a type of extra esophageal GERD, occurs from the retrograde movement of gastric contents (acid and enzymes such as pepsin) out of the esophagus into the larynx, hypopharynx, and oropharynx and subsequently causing localized inflammation [1, 2]. The most common symptoms of LPR are throat clearing (98.3%), persistent cough (96.6%), heartburn/dyspepsia (95.7%), globus sensation (94.9%), and voice quality change (94.9%). The physical examination related to LPR are arytenoid erythema (97.5%), vocal cord erythema (95.7%) and edema (95.7%), posterior commissure hypertrophy (94.9%), and arytenoid edema (94.0%) [3].

The diagnosis of Laryngopharyngeal reflux can be made with patient’s history, physical examination, and laryngoscopy findings. In 2002, Belafsky et al. developed reflux symptom index (RSI), which is a self-administered nine-item outcome instrument for patients with LPR. The score of 0 (no problem) to 5 (severe problem) represented the severity of each symptoms. The total RSI of more than 13 is considered abnormal [4]. Belafsky et al., also developed reflux finding score (RFS) to standardize the video laryngoscopic findings of LPR patients. The RFS consisted of eight-item abnormal findings ranging from 0 (no abnormal findings) to 26 (worst score). Patients with the score of more than seven are consistent with LPR [5]. Both the RSI and RFS instruments showed excellent reproducibility, reliability, and validity[4, 5].

The current treatments for LPR consist of lifestyle modifications, medical treatments, and surgical interventions in recalcitrant patients. Although many drugs were proposed to treat LPR, proton pump inhibitors (PPI) are the most widely accepted medications. Generally, patients who have failed 3-months conservative behavioral and medical treatments, further investigations are indicated. These include 24-h dual channel pH probe monitoring and conventional transoral esophagogastroduodenoscopy (EGD) [6]. However, conventional transoral EGD may lead to serious cardiopulmonary complications from sedation, such as hypoxemia and arrhythmia [7]. Also, conventional transoral EGD requires hospitalization, takes long time to perform, and needs high expenses for the operation room and sedation team. Therefore, in the past decade, much research has been focusing on the novel instrument which can visualize the esophagus as well as using a less invasive approach compared to the conventional EGD. Thus, transnasal esophagoscopy (TNE), a new examination technique was introduced. This procedure can be performed in out-patient settings under local anesthesia. As a result, the latter technique is known to be more feasible and cost effective. Also, the procedure requires less study duration and less complications are encountered.

Although TNE can be performed in many leading health care institutions in Thailand, there are limited studies regarding the use of TNE amongst Thai patients. Therefore, this study aims to evaluate the positive pathological findings, patient satisfaction, pain, and complications of TNE in patients who presented with LPR symptoms at HRH Princess Maha Chakri Sirindhorn Medical Center (MSMC), Thailand.

Materials and Methods

The study was a descriptive cross-sectional design, conducted between 1st January 2019 and 31st December 2019. Forty adult patients (over 18 years) with laryngopharyngeal reflux symptoms from MSMC, Nakhon Nayok, Thailand, were recruited to undergo transnasal esophagoscopy (TNE). The selection criteria included patients who had failed the treatment by proton pump inhibitors for at least 3 months and had RSI more than 13. Patients with abdominal pain, nausea and vomiting, history of head and neck cancers, and those on anticoagulants therapy were excluded from the study. Informed consent was obtained from all patient subjects. This study was approved by the Ethics Committee of Srinakharinwirot University (SWUEC/E-364/2561).

Data Collection

All participants were asked to provide information about their demographics using a standard questionnaire. Chief complaints associated with laryngopharyngeal reflux symptoms were recorded. Data regarding smoking and alcohol status (never versus stopped) were also collected. Clinical severity was evaluated based on laryngoscope findings using RSI and RFS. Dysphagia screening was examined using EAT-10 questionnaire.

TNE findings were recorded and evaluated by two experienced otolaryngologists. Patients satisfactions were recorded in a visual analogue scale (VAS) and pain scores were recorded using McGill pain score, which ranged from no pain (0) to excruciating pain (5). Complications from the TNE were also noted. All data were collected by the researcher and transferred to Microsoft Excel as raw data for statistical analysis.

Transnasal Esophagoscopy Technique

Local anaesthesia and decongestion were performed by nasal packing using cottonoid soaked with 10% xylocaine spray and 1% ephedrine. 10% xylocaine spray was also used for oropharynx anaesthesia. The patients were evaluated in upright position using Pentax flexible endoscope (EE1580K). 2% xylocaine jelly was applied at the tip of the scope before being advanced through the patient’s nasal cavity, nasopharynx, oropharynx, hypopharynx, supraglottis and glottis. Upon reaching the post cricoid area, 1% lidocaine without adrenaline was infiltrated through the scope’s working channel for local anaesthesia. The scope was then further advanced through the esophageal inlet in order to evaluate the entire length of the esophagus and the stomach. Air insufflation was used to enhance visualization. Patient with positive findings would be treated or referred according to standard treatment of the diagnosed condition.

Statistical Analysis

All statistical analysis was performed using STATA, version 13.0. The baseline characteristics and outcomes were statistically described as number, percentage, mean, standard deviation (SD), and range. The proportion of positive findings was calculated in accordance with the TNE findings. Chi-square and Fisher’s exact tests were used to process categorical variables. Comparisons between the continuous variables were analysed using independent t-test and Mann–Whitney U test. A p-value < 0.05 was considered statistically significant.

Results

After TNE was performed, all patients were divided into two groups, which were the positive TNE findings and the negative TNE findings groups. There was no significant difference between the two groups in terms of gender, age, BMI, history of alcohol, and history of smoking. (Demographic data of the patients are presented in Table 1) The RSI and EAT-10 self-assessment tools also showed no significant difference between the two groups. The RFS was lower in the positive TNE findings group but was not statistically significant. Our present study showed that the most common chief complaints of the laryngopharyngeal reflux patients were globus sensation and dysphagia. Although dysphagia and globus sensation were highest amongst the positive TNE findings group, there were no significant difference between the two patient groups in terms of presenting symptoms.

Table 1.

Demographic data

	Total n = 40	Positive TNE findings, n = 16/40 (40%)	Negative TNE findings, n = 24/40	P-value
Gender, male, n	13/40	5/16	8/24	0.890
Age, mean ± SD (range), year	53.83 ± 13.56 (29–78)	57.25 ± 15.14 (29–78)	51.54 ± 12.19 (29–70)	0.196
BMI, mean ± SD (range), kg/m2	24.69 ± 4.87 (15.80–38.28)	24.37 ± 6.10 (15.80–38.28)	24.90 ± 3.99 (18.63–32.89)	0.742
Smoking				0.188
None	25	10	15
Current	4	0	4
Stopped	11	6	5
Alcohol				0.777
None	28	11	17
Current	4	1	3
Stopped	8	4	4
RFS, mean ± SD (range)	5.60 ± 2.22 (2–10)	5.00 ± 2.06 (2–10)	6.00 ± 2.26 (3–10)	0.165
RSI, mean ± SD (range)	17.88 ± 4.40 (13–29)	18.12 ± 4.41 (13–29)	17.71 ± 4.49 (14–28)	0.726*
Eat 10, mean ± SD (range)	9.88 ± 5.33 (3–25)	10.06 ± 5.37 (4–20)	9.75 ± 5.41 (3–25)	0.858
Chief complaint, n				0.193
Globus	12	4	8
Sore throat	5	1	4
Heartburn	7	1	6
Dysphagia	9	6	3
Dysphonia	4	3	1
Throat clearing	2	1	1
Cough	1	0	1

*Mann–Whitney test

Table 2 shows positive endoscopic findings from TNE that led to the changes in management from previous LPR treatments. In our study, 16/40 patients (40%) had positive pathological findings that led to changes in management. Twenty-four patients had no identifiable pathologies from TNE examination. Thirteen patients with positive findings from TNE were treated with new medications according to the new diagnosis. Seven patients were referred to gastroenterology department for further management. Moreover, Table 3 shows patients’ satisfaction and pain scores from TNE procedure. The average satisfaction score on VAS was high and most patients were in the mild (18/40) and discomforting (11/40) groups in McGill pain score. One patient reported no pain at all (0), while no patients reported excruciating pain. There was no complication from TNE.

Table 2.

TNE findings

Findings	Number
Esophagitis	2
Esophageal candidiasis	2
Esophageal ulcer	2
Gastric ulcer	3
Vocal nodules	2
Neoplasm	1
Multiple ulcers (Esophagus and stomach)	4
Referral
None	9
GI	7
New medication	13

Table 3.

Number of patients and McGill Pain Score

Score	Number
0—No pain	1
1—Mild	18
2—Discomforting	11
3—Distressing	8
4—Horrible	2
5—Excruciating	0

Discussion

Generally, patients who have failed conservative measures for three months were indicated to undergo further investigations such as 24-h pH monitoring and conventional transoral EGD [6]. However, there are some limitations to EGD, as it requires hospitalization, sedation, and high expenses. In addition, complications from sedation may lead to cardiopulmonary events such as hypoxemia and arrythmia [7]. TNE, the use of a small caliber endoscope to examine the esophagus and stomach under local anesthesia in an out-patient setting, is known to be more cost effective, feasible, safe, and better tolerated compared to conventional EGD [12]. Due to the fact that sedation is not required, TNE also has less complications and takes less time to perform [7]. It has also been proven to have the same specificity and visual quality as conventional EGD [12].

This is the first study in Thailand to evaluate the efficacy of TNE in patients with laryngopharyngeal reflux symptoms. In this study, 40% of patients had positive TNE findings which resulted in changes in management. The results were in proximity to a previous study in Korea by Chung et al., which also reported 41.1% positive TNE finding amongst LPR patients [9]. Majority of chief complaints that led to changes in management in this study were globus sensation, heartburn, dysphagia, sore throat, dysphonia, esophagitis, esophageal candidiasis, esophageal ulcer, gastric ulcer, vocal nodules, tumor at right false vocal cord, and multiple esophageal with gastric ulcers. These results are in concordance with the previous studies by Howell et al., which reported globus, cough, trouble swallowing and dysphonia to be chief complaints that led to changes in management after TNE. [10] Alternatively, Chung et al., reported esophagitis to be the most common positive TNE pathological finding amongst LPR patients [11].

Postma et al., conducted the largest TNE case-series worldwide, which reported 50% positive findings from patients who undergo TNE due to various indications including reflux, globus sensation, dysphagia, head and neck cancer screening, biopsy of known lesions, evaluation for esophageal foreign bodies, tracheoscopy, dilation of esophageal stricture and tracheoesophageal puncture under direct vision [9]. Similarly, Howell et al. reported 51% positive findings which favored change in management after TNE [10]. While previous studies included various chief complaints and LPR patients regardless of previous treatments, the inclusion criteria of our study involved only LPR patients who had failed PPI treatment for at least three months, while patients with history of head and neck cancer were exclude. The difference in the inclusion criteria may explain the lower detection percentage (40%) in this study.

This study also evaluated demographic data of patients who favored changes in management after TNE. It was found that gender, age, BMI, RFS, RSI, Eat-10 were not significant predictive indicators. Instead, RFS was generally lower in the positive TNE findings patients. This result was similar to the findings of Howell et al. [10]. This may be because patients with higher RFS were generally more consistent with LPR diagnosis [5]. Therefore, the lower RFS group was more likely to yield positive other pathologies rather than LPR. Although, there were no significant difference in demographic data, 40% positive findings suggests that TNE should be performed in all LPR patients with failed medications because history, physical examination, questionnaires, and IDL cannot exclude a number of positive pathologies that would lead to changes in managements.

The inclusion criterion in this study was patients with LPR who have been treated with PPI twice daily for 3 months with no improvement of symptoms. The dosage of twice-daily PPI for GERD and once or twice-daily PPI for extraesophageal GERD were recommended prior to endoscopy according to the AGA Medical Position Statement on the Management of Gastroesophageal Reflux Disease [13]. The American Academy of Otolaryngology–Head and Neck Surgery recommended the minimum dosage of twice-daily PPI [2]. However, according to the study by Lechien et al. in 2020, the dosage and the duration remained controversial [14]. In this study, the group with negative TNE findings had no change in management following the procedure. This can be clarified as same medication, reduction in dosage, or no medication prescribed. This study may be beneficial for the de-escalation of PPI therapy in the negative TNE findings group. Additionally, clinicians could emphasize more on the non-medical treatments, such as life-style modifications, in this group of patients.

There were no reported complications due to the minimally invasive procedure and absent of sedation used during the study. This data is comparable to studies by Chung et al., and Aviv et al. which reported no complications and minor complication such as vasovagal syncope [11, 15]. The average visual analogue scale (VAS) on patient’s satisfaction from the procedure was 8.60 ± 1.43, which was comparable to Chung et al., who reported fair satisfaction from TNE based on VAS and Shaker that reported TNE as friendly for patients [8, 11]. The majority of the patients had mild pain according to the McGill pain score, which was in proximity to Chung et al. and Postma et al., who both reported pain from TNE as tolerable [9, 11]. Although, TNE was proven to be easy to perform, well tolerated and cost effective the procedure mainly focuses on the examination of the entire esophagus. For this reason, some gastric pathologies may be missed. In this research, a small sample was enrolled due to the limitation of study duration.

Conclusion

In conclusion, TNE is an efficient tool for otolaryngologists to evaluate pathological findings that would lead to the changes in management of LPR patients. Additionally, TNE can be done in outpatient setting and was proven to be safe, well tolerated and highly satisfied. Therefore, TNE should be performed as a confirmation diagnosis in LPR patients who had not responded well to PPI therapy for at least three months.

Funding

This study was funded by Faculty of Medicine, Srinakharinwirot University (597/2562).

Compliance with ethical standards

Conflict of interest

The authors declare that they have no conflict of interest.