Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis

Study Overview
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Brief Summary
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Patients with gallstone and confirmed common bile duct stones are registered in this study. The three managements for common bile duct stones are endoscopic sphincterotomy (EST), laparoscopic common bile duct exploration (LCBDE) and laparoscopic transcystic common bile duct exploration (LTCBDE). Patients will be assessed at baseline, preoperative investigations, operative method, operative time, conversion to open procedure, intraoperative and postoperative complications, and the presence of retained and recurrent stones. All patients were followed up for 3 years by telephone interview ang outpatient visits. Abdominal US and liver function tests were carried out whenever any abdominal symptom appeared during the follow-up period. If there were unusual findings, magnetic resonance cholangiopancreatography(MRCP) was carried out.

Official Title
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Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System

Conditions
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Gallstones, Cholelithiasis, Cholecystolithiasis, Choledocholithiasis

Intervention / Treatment
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* Procedure: endoscopic sphincterotomy
* Procedure: laparoscopic common bile duct exploration
* Procedure: laparoscopic transcystic common bile duct exploration
* Procedure: laparoscopic cholecystectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with age between 18 - 80 years. Patients diagnosed with gallstones. Patients diagnosed with common bile duct stone by one of the three exam (MRI、MRCP and CT). Patients diagnosed with common bile duct stone by intro-operative cholangiography or transcystic exploration. Patients accepted one of the three managements (EST+LC, LCBDE and LTCBDE). Exclusion Criteria: Combined with Mirizzi syndrome and intrahepatic bile duct stones Previous EST/endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic biliary drainage (PTBD) History of upper abdominal surgery. Serious heart,brain,lung, metabolic diseases history. Pregnant women Unwillingness or inability to consent for the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EST+LC group<br>Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy. | Procedure: endoscopic sphincterotomy<br>* Sphincterotomy (EST) is performed to remove the common bile duct stone.<br>Procedure: laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy is performed to remove the gallbladder.<br>|
| LCBDE+LC group<br>Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy. | Procedure: laparoscopic common bile duct exploration<br>* Transductal exploration was carried out to remove the common bile duct stone. Primary closure or a T tube drainage was performed according to the results of transductal surgery.<br>Procedure: laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy is performed to remove the gallbladder.<br>|
| LTCBDE+LC group<br>Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy. | Procedure: laparoscopic transcystic common bile duct exploration<br>* A wide local dissection of Calot's triangle is performed and a 2.8mm, 3-mm or 5-mm flexible choledochoscope according to the diameter of the cystic duct is inserted through the cystic duct into the common bile duct. After the common bile duct stone is removed, the cystic duct was ligated with Hem-o-lok.<br>Procedure: laparoscopic cholecystectomy<br>* Laparoscopic cholecystectomy is performed to remove the gallbladder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Adverse outcomes | The patients with complication / the total patients | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost-effectiveness ratio | the average incremental cost associated with 1 additional unit of the measure of effect | 3 years | 
| Hospital stay | The total days in hospital | 3 years | 
| Acute cholangitis rate | The patients with acute cholangitis / the total patients | 30 days | 
| Bile leakage rate | The patients with bile juice found in the abdominal cavity after procedures / the total patients | 30 days | 
| Stricture of the bile duct rate rate | The patients with any stricture appeared after the procedures / the total patients | 3 years | 
| Mortality | Number of death connected with the procedures and complications / total patients | 3 years | 
| Perforation Rate | The patients with perforation after the procedures / the total patients | 30 days | 
| Hemorrhage Rate | The patients with hemorrhage after the procedures / the total patients | 3 years | 
| Operation time | The total time of all the procedures (min) | 3 years | 
| Acute pancreatitis Rate | The patients with acute pancreatitis after the procedures / the total patients | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic transcystic common bile duct exploration, laparoscopic common bile duct exploration, endoscopic sphincterotomy,, cost-effective analysis