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

Recruiting

Conditions: ASA 1/2 pateints with concomitant CBD stones and gall stones

Registration Number: CTRI/2012/11/003118

Lead Sponsor: AIIMS

Brief Summary: IntroductionThe primary challenge in the management of common bile duct (CBD) stones in association with gallstones is to select the best strategy with regard to success, morbidity and cost-effectiveness. With the rapid development of endoscopic and laparoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) combined with LC has become the mainstream treatment for CBD stone and gallstone in most medical centers. With advances in laparoscopic technology, laparoscopic CBD exploration is becoming the procedure of choice for patients with CBD stones in centers with surgeons having adequate laparoscopic experience7. There is insufficient information in the literature on the practice of laparoscopic CBD exploration in cases of endoscopically irretrievable stones. This prospective comparative study has been designed to study the outcomes after primary laparoscopic CBD exploration and laparoscopic CBD exploration following unsuccessful endoscopic stone extraction.Materials and MethodsThis study will be carried out in the Department of Surgical Disciplines and Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi. The study will include 80 patients divided into two groups.

Group I: Patients with gallstones and common bile duct stones without any prior intervention

Group II: Patients with gallstones and common bile duct stones with prior attempts at endoscopic stone extraction

All the patients will undergo a single staged procedure i.e. laparoscopic cholecystectomy with laparoscopic common bile duct exploration and stone clearance (LC + LCBDE).

Success will be defined as removal of CBD stones and gallbladder by the intended approach in both the groups i.e. laparoscopic removal. The details of the patients and operative details will be entered in pre structured proforma. All patients will be followed postoperatively for a minimum of one year or till the time they are stone free. Postoperative course of the patients will be noted

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

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

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

Name	Time	Method
Complications, hospital stay, and cost effectiveness	Post operative

Trial Locations

Locations (1): All India Institute of Medical Sciences, New Delhi, India
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences, New Delhi, India
🇮🇳South, DELHI, India
Virinder Kumar Bansal
Principal investigator
01126593686
drvkbansal@gmail.com