Study Investigating the Best Method of Treatment of Bile Duct Stones in Higher Risk Patients
Not Applicable
Terminated
- Conditions
- CholedocholithiasisHigher Risk Patients
- Interventions
- Procedure: Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomyProcedure: Laparoscopic bile duct exploration during cholecystectomy
- Registration Number
- NCT00612846
- Lead Sponsor
- North Bristol NHS Trust
- Brief Summary
The aim of the trial is to compare two operations which are used to treat bile duct stones. The hypothesis of the study is that there is no difference between endoscopic sphincterotomy followed by laparoscopic cholecystectomy or laparoscopic bile duct exploration during laparoscopic cholecystectomy in the treatment of bile duct stones in higher risk patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 91
Inclusion Criteria
- Gallbladder stones
- At least strong evidence of bile duct stones (abnormal LFTs and dilated bile duct)
- Higher risk (>70yrs, >60yrs with co-morbidity, >50 with BMI>40)
Exclusion Criteria
- Not fit for general anaesthesia
- Cholangitis requiring emergency ERCP
- Previous upper GI surgery making ERCP impossible
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Endoscopic sphincterotomy and subsequent laparoscopic cholecystectomy - B Laparoscopic bile duct exploration during cholecystectomy -
- Primary Outcome Measures
Name Time Method Bile duct clearance Peri-operative
- Secondary Outcome Measures
Name Time Method Morbidity and mortality 30 day or directly relating to intervention Post-operative stay Post-operative stay Procedures per patient Interventions required to acheive duct clearance Conversion to open surgery Peri-operative