Comparision of Endoscopic and Laparoscopic removal of Large Bile Duct Stone: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
Gall bladder stones are associated with common bile duct (CBD) stones in 7-12% of patients. The preferred method of removal of bile duct stone is endoscopic retrograde cholangiopancreatography (ERCP). However the success rate of bile duct stone removal decreases with increase in size of stone especially ≥ 1.5 cm stones as well as the number of procedures. On the contrary laparoscopic CBD exploration (LCE) is a single stage procedure with the advantage of having cholecystectomy in same setting, but it is associated with complications such as bile leak, conversion to open surgery and prolonged hospitalization. It is not clear which is better for large CBD stone (≥ 1.5 cm). Our aim to compare both the modalities in patients with CBD stone of size 1.5 cm or more.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Open Label
Eligibility Criteria
- Ages
- 18.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
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.
Time Frame: at 1 month
Secondary Outcomes
- 1. Complications of the intervention(2. Procedure time in minutes)