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

A Prospective Study To Compare The Outcomes After Primary Laparoscopic Exploration Of Common Bile Duct And Laparoscopic Exploration Following Failed Endoscopic Stone Extraction In Patients With Concomitant Gall Stones And Common Bile Duct Stones

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/11/003118
Enrollment
80
Registered
2012-11-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- ASA 1/2 pateints with concomitant CBD stones and gall stones

Interventions

Intervention1: Laparoscopic Common bile duct exploration: Group I: Patients with gallstones and common bile duct stones without any prior intervention Group II: Patients with gallstones and common bil

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
â?¢ To assess the success and complications of laparoscopic CBD exploration for choledocholithiasis after unsuccessful endoscopic stone extraction to extract common bile duct stones â?¢ To compare the success, ease of surgery and complications between primary laparoscopic CBD exploration and laparoscopic CBD exploration following unsuccessful endoscopic stone extraction 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

MeasureTime frame
Complications, hospital stay, and cost effectivenessTimepoint: Post operative—

Countries

India

Contacts

Public ContactKarthik Rajan

All India Institute of Medical Sciences, New Delhi, India

drvkbansal@gmail.com01126593686

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026