Optimization and Cost-effective Analysis of Secondary Biliary Stones' Managements - A Multicenter, Prospective and Retrospective Cohort Study Based on Case Register System
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Beijing Friendship Hospital
- Enrollment
- 2,700
- Locations
- 1
- Primary Endpoint
- Rate of Adverse outcomes
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Rate of Adverse outcomes
Time Frame: 3 years
The patients with complication / the total patients
Secondary Outcomes
- Hospital stay(3 years)
- Stricture of the bile duct rate rate(3 years)
- Operation time(3 years)
- Bile leakage rate(30 days)
- Mortality(3 years)
- Perforation Rate(30 days)
- Acute cholangitis rate(30 days)
- Hemorrhage Rate(3 years)
- Acute pancreatitis Rate(30 days)
- Incremental cost-effectiveness ratio(3 years)
Investigators
Zhongtao Zhang
Doctor
Beijing Friendship Hospital