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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- AIIMS
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- •To compare the success, ease of surgery and complications between primary laparoscopic CBD exploration and laparoscopic CBD exploration following unsuccessful endoscopic stone extraction
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Not Applicable
- Masking
- Not Applicable
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
•To compare the success, ease of surgery and complications between primary laparoscopic CBD exploration and laparoscopic CBD exploration following unsuccessful endoscopic stone extraction
Time Frame: 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
•To assess the success and complications of laparoscopic CBD exploration for choledocholithiasis after unsuccessful endoscopic stone extraction to extract common bile duct stones
Time Frame: 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 Outcomes
- Complications, hospital stay, and cost effectiveness(Post operative)