Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis

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

Sponsors

Lead Sponsor: Beijing Friendship Hospital

Collaborator: Peking University First Hospital
Xuanwu Hospital, Beijing
Luhe Hospital, Capital Medical University
Peking University Third Hospital
China-Japan Friendship Hospital
Beijing Tongren Hospital
LanZhou University
The First Affiliated Hospital of Dalian Medical University
Shanghai Zhongshan Hospital
Peking University
Peking Union Medical College Hospital

Source Beijing Friendship Hospital
Brief Summary

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.

Overall Status Unknown status
Start Date 2015-08-01
Completion Date 2018-12-30
Primary Completion Date 2018-12-15
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Rate of Adverse outcomes 3 years
Secondary Outcome
Measure Time Frame
Incremental cost-effectiveness ratio 3 years
Hospital stay 3 years
Acute cholangitis rate 30 days
Bile leakage rate 30 days
Stricture of the bile duct rate rate 3 years
Mortality 3 years
Perforation Rate 30 days
Hemorrhage Rate 3 years
Operation time 3 years
Acute pancreatitis Rate 30 days
Enrollment 2700
Condition
Intervention

Intervention Type: Procedure

Intervention Name: endoscopic sphincterotomy

Description: Sphincterotomy (EST) is performed to remove the common bile duct stone.

Arm Group Label: EST+LC group

Intervention Type: Procedure

Intervention Name: laparoscopic common bile duct exploration

Description: 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.

Arm Group Label: LCBDE+LC group

Intervention Type: Procedure

Intervention Name: laparoscopic transcystic common bile duct exploration

Description: 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.

Arm Group Label: LTCBDE+LC group

Intervention Type: Procedure

Intervention Name: laparoscopic cholecystectomy

Description: Laparoscopic cholecystectomy is performed to remove the gallbladder.

Eligibility

Sampling Method:

Non-Probability Sample

Criteria:

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

80 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Zhongtao Zhang, Doctor Study Chair Beijing Friendship Hospital
Location
Facility: Beijing Friendship Hospital
Location Countries

China

Verification Date

2018-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Beijing Friendship Hospital

Investigator Full Name: Zhongtao Zhang

Investigator Title: Doctor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: EST+LC group

Description: Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy.

Label: LCBDE+LC group

Description: Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy.

Label: LTCBDE+LC group

Description: Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy.

Acronym CREST Choles
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

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