Chinese Registry Study on Treatment of Cholecysto-Choledocholithiasis (CREST Choles)

Capital Medical University

Status: Unknown

Conditions: Gallstones; Cholecystolithiasis; Cholelithiasis; Choledocholithiasis

Treatments: Procedure: laparoscopic cholecystectomy; Procedure: laparoscopic common bile duct exploration; Procedure: endoscopic sphincterotomy; Procedure: laparoscopic transcystic common bile duct exploration

Study type: Observational

Funder types: Other

Identifiers

NCT02554097

CR-CREST Choles

Details and patient eligibility

About

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.

Enrollment: 2,700 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,700 participants in 3 patient groups

EST+LC group

Description:

Patients accept the management of endoscopic sphincterotomy and laparoscopic cholecystectomy.

Treatment:

Procedure: laparoscopic cholecystectomy

Procedure: endoscopic sphincterotomy

LCBDE+LC group

Description:

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

Treatment:

Procedure: laparoscopic cholecystectomy

Procedure: laparoscopic common bile duct exploration

LTCBDE+LC group

Description:

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

Treatment:

Procedure: laparoscopic cholecystectomy

Procedure: laparoscopic transcystic common bile duct exploration