Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis

• Conditions: Cholelithiasis; Gallstones; Choledocholithiasis; Cholecystolithiasis
• Interventions: Procedure: endoscopic sphincterotomy; Procedure: laparoscopic transcystic common bile duct exploration; Procedure: laparoscopic common bile duct exploration; Procedure: laparoscopic cholecystectomy

• Registration Number: NCT02554097
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-15
• Study First Submitted QC: 2015-09-17
• Study First Posted: 2015-09-18
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-22
• Last Update Posted: 2018-11-27
• Primary Completion: 2018-12-15
• Study Completion: 2018-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2700

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
EST+LC group	endoscopic sphincterotomy	Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy.
LTCBDE+LC group	laparoscopic transcystic common bile duct exploration	Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy.
EST+LC group	laparoscopic cholecystectomy	Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy.
LCBDE+LC group	laparoscopic cholecystectomy	Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy.
LCBDE+LC group	laparoscopic common bile duct exploration	Patients accept the management of laparoscopic common bile duct exploration and laparoscopic cholecystectomy.
LTCBDE+LC group	laparoscopic cholecystectomy	Patients accept the management of laparoscopic transcystic common bile duct exploration and laparoscopic cholecystectomy.

Primary Outcome Measures

Name	Time	Method
Rate of Adverse outcomes	3 years	The patients with complication / the total patients

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China