NCT02554097

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,700 (estimated)
• Sponsor: Beijing Friendship Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gallstones
• Cholelithiasis
• Cholecystolithiasis
• Choledocholithiasis

Interventions

Type	Name	Description
PROCEDURE	endoscopic sphincterotomy	Sphincterotomy (EST) is performed to remove the common bile duct stone.
PROCEDURE	laparoscopic common bile duct exploration	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.
PROCEDURE	laparoscopic transcystic common bile duct exploration	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.
PROCEDURE	laparoscopic cholecystectomy	Laparoscopic cholecystectomy is performed to remove the gallbladder.

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-12-15
• Completion: 2018-12-30
• First posted: 2015-09-18
• Last updated: 2018-11-27

Locations

1 site across 1 country: China