Study of comparison of endoscopic and surgical removal of large stones in bile duct
Phase 3
- Conditions
- Health Condition 1: K838- Other specified diseases of biliary tract
- Registration Number
- CTRI/2019/01/017055
- Lead Sponsor
- Department of Gastroenterology and Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Patients with a common bile duct stone of size 1.5 cm or more detected on a magnetic resonance cholangiopancreatography (MRCP) with or without gall stones, both pre and post cholecystectomy will be included in the study.
Exclusion Criteria
1.Presence of acute cholecystitis
2.Presence of acute cholangitis
3.Patients with obstructive jaundice with a serum bilirubin level higher than 10 mg/dl
4.Patients with a CBD diameter less than 10 mm
5.Patients with a history of hepatobiliary surgery other than cholecystectomy
6.Patient with uncorrectable coagulopathy
7.Patient with American Society Anaeathesiology (ASA) class 3 or more
8.Patient refusal to give consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be a composite of complete removal of stone in the bile duct by laproscopic CBD exploration (LCE) or endoscopic method, need of more than two attempts of ERCP for bile duct clearance or occurrence of major complication.Timepoint: at 1 month
- Secondary Outcome Measures
Name Time Method 1. Complications of the intervention <br/ ><br>2. Procedure time in minutes <br/ ><br>3. Difficulty of the procedure <br/ ><br>4. Hospital stay <br/ ><br>5.Cost of the procedure <br/ ><br>6. Cost effectivenessTimepoint: at 1 months