Study of comparison of endoscopic and surgical removal of large stones in bile duct
- Conditions
- Other specified diseases of biliary tract,
- Registration Number
- CTRI/2019/01/017055
- Lead Sponsor
- Department of Gastroenterology and Department of Surgery
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 40
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.
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. at 1 month
- Secondary Outcome Measures
Name Time Method 1. Complications of the intervention 2. Procedure time in minutes
Trial Locations
- Locations (1)
All India Institute of Medical Sciences
🇮🇳South, DELHI, India
All India Institute of Medical Sciences🇮🇳South, DELHI, IndiaSoumya Jagannath MahapatraPrincipal investigator9990420767soumyajagannath@yahoo.com