MedPath

to study whether laparoscopic bile duct exploration after failed endoscopy â?? does it differ from a primary bile duct exploratio

Not Applicable
Conditions
Health Condition 1: null- ASA 1/2 pateints with concomitant CBD stones and gall stones
Registration Number
CTRI/2012/11/003118
Lead Sponsor
AIIMS
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Open to Recruitment
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

1.Patients with both symptomatic gall stones and choledocholithiasis

2.Patients in whom a prior ERCP had failed to extract a CBD stone

Failure of ERCP will be defined as:

1.Unsuitable anatomy such as gastric outlet obstruction, large periampullary diverticulum

2.Failure to cannulate the bile duct

3.Failure to perform adequate sphincterotomy

4.Failure to extract the stone for various reasons such as large stone, impacted stones and/or multiple stones

Exclusion Criteria

1.Patients with acute cholecystitis

2.Patients with acute cholangitis

3.Patients with obstructive jaundice with serum bilirubin > 15mg/dl

4.Patients with post ERCP pancreatitis

5.Patients who do not give consent for participate in the study

6.Patients with previous hepatobiliary surgery

7.Patients with morbid obesity

8.Patients with uncorrectable coagulopathy

9.Patients unfit for GA

10.Patients with significant comorbid conditions

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
â?¢To assess the success and complications of laparoscopic CBD exploration for choledocholithiasis after unsuccessful endoscopic stone extraction to extract common bile duct stones <br/ ><br>â?¢To compare the success, ease of surgery and complications between primary laparoscopic CBD exploration and laparoscopic CBD exploration following unsuccessful endoscopic stone extraction <br/ ><br>Timepoint: All patients will be followed postoperatively at 1 week, 3 months, 6 months and at one year or till the time they are stone free. Postoperative course of the patients will be noted
Secondary Outcome Measures
NameTimeMethod
Complications, hospital stay, and cost effectivenessTimepoint: Post operative
© Copyright 2025. All Rights Reserved by MedPath