Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis and Biliary Complications After Stone Clearance in Patients Awaiting Cholecystectomy-A Multicentric Randomized Controlled Trial (STONE Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Choledocholithiasis
- Sponsor
- Asian Institute of Gastroenterology, India
- Enrollment
- 480
- Primary Endpoint
- To compare the CDL recurrence rate between the 2 groups
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
We planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance
Detailed Description
Patients with cholelithiasis can have presence of concomitant choledocholithiasis (CDL) in upto 30%. These stones may remain asymptomatic or cause obstructive jaundice and complications like cholangitis and pancreatitis. In situations where there is a failure of CDL clearance during endoscopic retrograde cholangiography (ERC), biliary stenting is recommended to prevent complications. However, the role of prophylactic biliary stenting in situations where CDL clearance has been achieved, and the patient is awaiting cholecystectomy is debatable. One retrospective study showed benefit while a small prospective study and a retrospective study did not show benefit of prophylactic biliary stenting. Moreover, a randomized controlled trial addressing this question is lacking. Hence, we planned this multicenter randomized controlled trial to study the role of a prophylactic biliary stent in recurrence of stones and biliary complications in patients awaiting cholecystectomy after biliary stone clearance.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age between 18-80 years
- •Cases of cholelithiasis with concomitant CDL in whom CBD clearance is achieved will be included.
Exclusion Criteria
- •Informed consent not available
- •Patients opting for single stage surgery
- •Previous hepatobiliary surgery
- •Failure to completely clear CDL on ERC
- •Concomitant benign biliary strictures (like chronic pancreatitis, portal cavernoma cholangiopathy, post cholecystectomy, primary biliary cholangitis related)
- •Previous cholecystectomy patients
- •Associated malignancy
- •Coagulopathy(INR\>1.5, platlets\<1lac)
- •Severe cholangitis
Outcomes
Primary Outcomes
To compare the CDL recurrence rate between the 2 groups
Time Frame: 3 Months
Secondary Outcomes
- To compare the biliary complications between the 2 groups(3 Months)
- To compare the pancreatic complications between the 2 groups -To compare the need for repeat ERC between the 2 groups The outcomes will be compared during the time period of 3 months irrespective of the timing of cholecystectomy.(3 Months)