Efficacy analysis of hybrid operating room-based laparoscopic cholecystectomy combined with intraoperative endoscopic retrograde cholangiopancreatography in the treatment of cholelithiasis combined with choledocholithiasis – A case–control study

Abstract

Objective:

The objective is to compare the therapeutic effects of laparoscopic cholecystectomy (LC) combined with intraoperative endoscopic retrograde cholangiopancreatography (ERCP) in hybrid operating room and ERCP + LC under traditional conditions in the treatment of cholelithiasis and choledocholithiasis.

Materials and Methods:

Data of 82 patients with cholelithiasis complicated with choledocholithiasis treated by our centre from November 2018 to March 2021 were retrospectively analysed. Amongst them, 40 patients treated with LC combined with intraoperative ERCP in a hybrid operating room were placed into Group A, and 42 patients treated with ERCP first followed by LC under traditional conditions were placed into Group B. The differences in operative time, intraoperative blood loss, surgical success rate, stone clearance rate, pain score, exhaust time, ambulation time, post-operative complications, length of hospital stay, hospitalisation cost and other indicators between the two groups were compared.

Results:

There were no significant differences in operative time, intraoperative blood loss, surgical success rate and stone clearance rate between the two groups (P > 0.05), while there were significant differences in post-operative pain score, exhaust time, ambulation time, length of hospital stay, hospitalisation cost and complications (P < 0.05).

Conclusion:

LC combined with intraoperative ERCP in hybrid operating room for the treatment of cholelithiasis combined with choledocholithiasis has a better therapeutic effect than traditional ERCP followed by LC, which is worthy of further popularization. Notably, the reasonable selection should be made based on patients’ own conditions and hospital facilities.

INTRODUCTION

In China, cholelithiasis is a common clinical disease mainly characterised by cholelithiasis, with an incidence of about 6.6%. The proportion of women is larger than men in patients with cholelithiasis, and about 10% of them are accompanied by choledocholithiasis, mostly secondary stones. According to foreign reports, such patients accompanied by choledocholithiasis account for 9.2%–33.0%,[1] and their life and health are seriously affected. The traditional treatment method for cholelithiasis is choledocholithotomy + T-tube drainage, which has a history of more than 100 years and has clear therapeutic effect. T-tube drainage can prevent bile leakage and other complications caused by duodenal papilledema-induced choledocholithotomy. In case of residual or recurrent stones, secondary stone extraction through sinus can be performed. However, this operation has a large trauma, slow post-operative recovery, high incidence of complications such as bile drainage and wound infection.

In recent years, with the improvement of endoscopic machines and techniques, endoscopic retrograde cholangiopancreatography (ERCP) stone extraction followed by laparoscopic cholecystectomy (LC) is a common treatment method for cholelithiasis.[2] However, ERCP is usually performed by endoscopic sphincterotomy (EST) and often causes nipple bleeding, intestinal reflux and pancreatitis, which in turn causes repeated biliary tract infection, stone recurrence and other problems.[3] Since December 2019, our hospital has carried a comparison on the therapeutic effects of LC combined with intraoperative ERCP in hybrid operating room and ERCP + LC under traditional conditions in the treatment of cholelithiasis and choledocholithiasis and now it is reported as follows.

MATERIALS AND METHODS

General data

Data of 174 patients diagnosed with cholelithiasis combined with choledocholithiasis in our hospital from November 2018 to March 2021 were retrospectively analysed. Inclusion criteria: (1) diagnosed as cholelithiasis combined with choledocholithiasis by B-ultrasound, computed tomography or magnetic resonance cholangiography; (2) choledocholithiasis <1.5 cm, number <5. Exclusion criteria: (1) complicated with serious cardiovascular and cerebrovascular diseases; (2) complicated with acute pancreatitis, severe biliary tract infection, and malignant tumor; and (3) previous history of biliary tract surgery or multiple ERCP. Finally, a total of 82 patients were enrolled. According to different surgical methods, 40 patients who underwent LC combined with intraoperative ERCP in hybrid operating room were placed into Group A. The remaining 42 patients who underwent ERCP lithotomy in the digital gastrointestinal machine room before elective LC in operating room were placed into Group B. The clinical data of the two groups, including gender, age, alanine transaminase, total bilirubin, white blood cell and number of stones and diameter of stones, were compared, and there was no statistical difference [P > 0.05, Table 1].

Table 1.

Comparison of clinical data between the two groups

Characteristics	Group A (n=40)	Group B (n=42)	t/χ2	P
Age (years)	60.5±8.5	63.9±11.6	1.27	0.198
Gender (male/female)/case	22/18	27/15	0.735	0.391
ALT (U/L)	91.6±21.5	96.8±27.6	0.148	0.883
Total bilirubin (µmol/L)	46.6±13.9	54.7±7.8	1.16	0.244
WBC (×109/L)	12.8±3.8	9.5±4.4	0.68	0.495
Number of stones	1.64±0.76	1.60±0.76	0.20	0.84
Diameter of stones (mm)	12.08±2.25	12.86±2.61	−1.41	0.16

ALT: Alanine transaminase, WBC: White blood cell

Therapeutic methods

Group A (laparoscopic cholecystectomy combined with intraoperative endoscopic retrograde cholangiopancreatography)

In the hybrid operating room, patients were positioned in a supine position. The laparoscopic three-hole method was used to remove the gallbladder. During this process, the cystic duct was first completely free and remained, and then was ligated. A small hole was made in the proximal part of the cystic duct with scissors, through which a yellow zebra guidewire was introduced to the duodenum. Then, the pneumoperitoneum was removed, and the duodenoscope was introduced into the duodenal papilla. The guidewire was pulled out of the body by a stone basket, and a knife was inserted along the guidewire for cholangiopancreatography to determine choledocholithiasis. Afterwards, duodenal papillectomy was performed, or a cylindrical balloon was inserted into dilate duodenal papillae, followed by biliary lithotomy and indentation of nasobiliary duct. After the stone was removed, pneumoperitoneum was re-established and cholecystectomy was performed routinely [Figure 1]. Anti-infection treatment was routinely given after surgery, and nasobiliary angiography was performed 48 h after surgery, which can be removed if there were no residual stones.

Figure 1.

LC combined with intraoperative ERCP in the hybrid operating room. (a and b) Panorama of hybrid operating room; (c) Cholecystotomy; (d) Insert ureteral catheter and guidewire from cystic duct; (e and f) Duodenoscope; (g) The guidewire is inserted the duodenal papilla from the cystic duct; (h) The guidewire is clamped by a stone basket; (i) Fluoroscopy showed the guidewire in the common bile duct; (j) The balloon dilates the nipple; (k) Stone is removed by the basket. LC: Laparoscopic cholecystectomy, ERCP: Endoscopic retrograde cholangiopancreatography

Group B (endoscopic retrograde cholangiopancreatography followed by laparoscopic cholecystectomy)

In the digital gastrointestinal machine room of our hospital, patients were in the prone position and given sedative. The duodenoscope was routinely inserted into the duodenal papilla, and papillary Oddi’s sphincterotomy and balloon dilation were performed. Stone removal was performed with a stone basket, and nasobiliary drainage was routinely placed after surgery. After 1–2 days of stabilisation and the patients having no obvious discomfort, LC was performed in the ordinary operating room at an elective time, and nasobiliary angiography was performed 2 days after the operation. If no residual stones were found, the nasobiliary would be removed. If there are still stones, ERCP should be performed again. In patients with pancreatitis after ERCP surgery, LC was generally performed after the management of acute pancreatitis.

Post-operative treatment

Patients in both groups were monitored for vital signs and abdominal conditions, fasted for 6 h and changed to liquid diet, and given antibiotics and conventional infusion support treatment. Serum amylase level in Group A was detected at night and in the morning of the 1^st post-operative day. For example, amylase was normally given in semi-liquid on the 1^st post-operative day. If abdominal pain or elevated serum amylase level occurred, fasting was prolonged and the acute pancreatitis treatment regimen was followed. Abdominal signs and serum amylase level of patients in Group B were monitored after ERCP. If patients had no severe abdominal pain and blood amylase was normal, LC was performed 1–2 days later. If patients had significantly increased amylase accompanied by abdominal pain, treatment plans related to acute pancreatitis would be followed.

Observational indicators

Operation-related indicators included operative time (single operative time for Group A, the sum of the two operative times for Group B), intraoperative blood loss, surgical success rate and stone clearance rate. Post-operative recovery indicators included post-operative pain score, exhaust time, ambulation time, length of hospital stay and hospitalisation cost. Post-operative complications include post-operative nipple bleeding, cholangitis, hyperamylasaemia and acute pancreatitis. The above indicators were statistically analysed in the two groups.

Statistical analysis

SPSS version 22.0 (SPSS, Chicago, IL, USA) statistical software was used for statistical analysis. Measurement data were expressed as mean ± standard deviation. Independent sample t-test was used for data comparison between groups, and Chi-square test was used for counting data comparison. P < 0.05 indicated that the difference was statistically significant.

RESULTS

Operation-related indicators

There were no significant differences in operative time, intraoperative blood loss, surgical success rate and stone clearance rate between the two groups (P > 0.05). Thirty-nine patients in Group A were successfully treated with LC combined with intraoperative ERCP, including 14 patients with stones size from 0.5 to 1 cm, 16 patients with stones size <0.5 cm, and the remaining 6 patients without visible stones. In Group B, 15 cases had stone diameter >1 cm, 12 cases had stone diameter of 0.5–1 cm, 9 cases had stone diameter <0.5 cm and the remaining 6 cases had no visible stone. Serum amylase increased in 6 patients in Group A after operation, which was three times higher than the normal value, and no obvious acute pancreatitis was observed. Two patients with bloody bile duct who underwent nasobiliary drainage recovered after conservative treatment. There were no serious complications such as abdominal bile leakage or perforation. One case was changed to laparoscopic common bile duct exploration (LCBDE) due to large calculi. In Group B, serum amylase level increased in 16 patients after operation, and 5 cases were three times higher than the normal value. Amongst them, 1 case developed severe necrotising pancreatitis, and LC was performed again after conservative treatment for more than 20 days. One case also underwent LCBDE for choledocholithiasis due to the large number of choledocholithiasis and difficulty in removal. The operation-related indicators are shown in Table 2.

Table 2.

Operation-related indicators

Group	Operative time (min)	Intraoperative blood loss (mL)	Surgical success rate (%)	Stone clearance rate (%)
Group A (n=40)	109.7±9.2	16.3±9.2	39 (97.2)	40 (100)
Group B (n=42)	113.7±12.9	19.3±8.8	41 (95.5)	41 (97.7)
t/χ2	1.42	0.02	0.001	0.00
P	0.151	0.982	0.972	1.000

Post-operative recovery indicators

The post-operative pain score of Group A was lower than that of Group B, and the exhaust time and ambulation time were significantly earlier than those of Group B, with statistical significance (P < 0.05). The length of hospitalisation and hospitalisation cost in Group A were significantly less than those in Group B, with statistical significance [P < 0.05, Table 3].

Table 3.

Post-operative recovery indicators

Group	Post-operative pain score 6 h (point)	Post-operative exhaust time (h)	Ambulation time (h)	Length of hospitalization (day)	Hospitalization cost (ten thousand yuan)
Group A (n=40)	2.9±0.6	15.4±4.4	8.4±2.2	4.2±1.3	1.8±0.3
Group B (n=42)	3.2±0.7	18.8±5.9	13.1±3.6	8.2±1.9	2.7±0.6
t/χ2	2.70	3.22	6.80	11.89	9.81
P	0.005	0.001	0.000	0.000	0.000

Post-operative complication indicators

The post-operative complications such as duodenal papilla haemorrhage, cholangitis, hyperamylasaemia and pancreatitis in Group A were significantly less than those in Group B, with statistical significance [P < 0.05, Table 4].

Table 4.

Post-operative complication indicators

Group	Duodenal papilla hemorrhage	Cholangitis	Hyperamylasemia	Acute pancreatitis	Total complications
Group A (n=40)	0	0	6	0	1
Group B (n=42)	2	2	16	5	9
χ 2			5.567	4.515	17.273
P			0.018	0.034	0

DISCUSSION

With the improvement in living standards, the incidence of cholelithiasis is increasing, and many patients often develop secondary choledocholithiasis. Along with the development of the endoscopic technique, the most common surgical procedure is ERCP followed by LC, which reduces the risk of surgery, but also increases the pain of the surgery, prolongs the length of hospitalization and increases hospitalization cost, In addition, EST is often performed in ERCP, which damages the function of papillary Oddi’s sphincter, and was often associated with post-operative cholangitis such as abdominal pain, fever and jaundice, and some patients also suffered acute pancreatitis and other serious complications.[4] The feasibility of LC + LCBDE in the treatment of cholelithiasis combined with choledocholithiasis.[5] Meta-analysis reports and retrospective studies by foreign researchers also found that LC + LCBDE method has a high success rate of stone removal, while the length of hospital stay and hospitalisation cost were lower than ERCP/EST + LC, without statistically significant difference in the incidence of complications between the two groups.[6] However, LC + LCBDE destroys the original integrity of the biliary tract, and the bile duct wall after healing is often accompanied by the stricture of the common bile duct and the recurrence of calculi. Meanwhile, in some patients, the indwelling of the T-tube seriously affects their quality of life.[7,8]

In recent years, with the establishment of the hybrid operating room in our hospital, a new treatment method for patients with cholelithiasis and choledocholithiasis has been brought. A hybrid operating room, also known as composite integrated operating room, refers to the comprehensive integration of medical real-time imaging equipment such as angiography, medical surgical equipment such as digital subtraction angiography interventional therapy and traditional surgical equipment in the same operating room space.[9] Thus, the multidisciplinary treatment of tumour, vascular, heart, nerve and other complex diseases can be carried out jointly. In addition, multiple procedures (including imaging, biopsy, anaesthesia, diagnosis, intervention and radiation therapy) can be met in a hybrid operating room compared with a traditional operating room, and the number of fasting anaesthesia sessions, operation time and the risk of bleeding from transportation between operating rooms were reduced.[10,11]

Our department takes the lead in carrying out LC combined with intraoperative ERCP under general anaesthesia in the hybrid operating room, which combined choledocholithotomy with cholecystectomy, without the need to place the T-tube in traditional surgery, and without abdominal distension, nausea and other discomfort common in ERCP under local anaesthesia. The patients’ medical experience has been significantly improved. The experience of this surgical method is summarised as follows: (1) improve the medical experience and surgical success rate. In this study, Group B patients underwent conventional one-stage ERCP and second-stage LC, but patients during ERCP operation, were often in the prone position with consciousness. Only conventional analgesic sedatives were given, and patients often felt nausea and vomiting, especially some elderly patients failed surgery due oxygen desaturation during endoscope insertion. In Group A, nausea and vomiting were greatly improved under general anaesthesia in hybrid operating room. When ERCP was performed simultaneously with LC, the possibility of stone residual was avoided because the stone was removed under X-ray fluoroscopy. Although compared with Group B patients, the stone clearance rate in Group A was not significantly improved. (2) Increase social benefits. Although there were no significant differences in operative time, intraoperative blood loss, surgical success rate and stone clearance rate between the two groups, LC combined with intraoperative ERCP in the hybrid operating room for Group A significantly shortened post-operative hospital stay and significantly reduced hospitalization costs. (3) Reduce medical risks. During ERCP for Group B patients, selective bile duct intubation is often difficult and time-consuming with guidewires, and there is often a risk of entering the pancreatic duct, to patients with post-operative appear high blood amylase or complications Post-operative complications such as hyperamylasaemia or acute pancreatitis would occur. In Group A, the guidewire first entered the common bile duct and then duodenal cavity, thus directly avoiding the possibility of the guidewire straying into the pancreatic duct. In addition, patients in Group B often received Oddi’s sphincterotomy, while patients in Group A generally received simple balloon dilation, which protected the function of Oddi’s sphincter to prevent intestinal fluid reflux and avoided post-operative cholangitis and stone recurrence, and the results were consistent with previous reports.[12] (4) Improve treatment efficiency. In addition to the perfect hardware conditions of the hybrid operating room, a corresponding technical team is also required. At present, our department has a team consisting of 7 doctors who are proficient in ERCP and laparoscopic operation skills. At least one ERCP doctor is cultivated every year. Compared ERCP stone extraction is usually performed by gastroenterologists in most hospitals, ERCP in our hospital avoids the communication and waiting time between departments and greatly reduces the pre-operative waiting time of patients.

However, at present, LC combined with intraoperative ERCP lithotomy in hybrid operating room for the treatment of cholelithiasis and choledocholithiasis still has certain limitations: (1) Due to the long medical history of many patients, the diameter and number of common bile duct calculi are large, especially for patients with stone diameter >1.5 cm and the number >5, if LC combined with intraoperative ERCP is performed, the operation time will be prolonged and there will be residual calculi; (2) The guidewire may not always be inserted into the duodenum from the cystic duct. If this is the case, conventional ERCP can be replaced. (3) Hu et al.[13] reported that because the patient is in supine position, compared with conventional prone position, duodenoscopy is more difficult, and time-consuming to operate, which often requires senior doctors to operate. (4) After ERCP, when laparoscopic pneumoperitoneum is re-established, obvious gastric and intestinal dilatation is often found, affecting the surgical field of vision, which requires full free of gallbladder triangle before ERCP and vacuuming of duodenum and gastric gas after ERCP, so that the gallbladder can be successfully removed later.

For LC combined with ERCP, we have gathered the following experience: (1) Before ERCP, the surgeon can clamp the intestinal canal at the beginning of the jejunum to reduce the passage of gas into the small intestine, which can help remove the gallbladder after ERCP and reduce post-operative abdominal distension. (2) After the cholecystectomy, a ureteral catheter can be inserted and then the yellow zebra guidewire can pass through the ureteral catheter, which will improve the success rate of guidewire insertion. (3) It is difficult to insert duodenoscope after endotracheal intubation. Anaesthesiologists can elevate the mandible of the patient to facilitate duodenoscope entry. (4) Intraoperative ERCP patients are in supine position, which increases the difficulty of duodenoscope insertion. Therefore, the surgeon should be highly skilled in adjusting the duodenoscope to an appropriate position. For inexperienced doctors, it may cause serious complications, such as perforation.[14] (5) Before exiting the duodenoscope, the gas in the duodenum and gastric lumen should be sucked as much as possible to facilitate subsequent cholecystectomy. (6) Placement of nasobiliary duct is recommended to reduce biliary pressure, reduce post-operative abdominal biliary leakage, observe whether duodenal papilla bleeding, and reduce the occurrence of biliary tract infection.

CONCLUSION

In summary, LC combined with intraoperative ERCP in the hybrid operating room for the treatment of cholelithiasis and choledocholithiasis in our hospital has achieved good efficacy, high success rate of treatment, fewer post-operative complications and good social benefits, which is worth further popularisation. However, due to the particularity of the hybrid operating room, treatment plan should be reasonably selected combined with patients’ own conditions. In addition, this study was a single-centre with a small number of cases and a short period of time. Further follow-up is still needed for long-term efficacy.

Financial support and sponsorship

This study was supported by the study on the treatment of electronic choledochoscope combined with U100 laser in the treatment of complex intrahepatic bile duct stones (20EZB08).

Conflicts of interest

There are no conflicts of interest.