Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis

Asian Institute of Gastroenterology, India480 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

DOUBLE

Enrollment

480

Conditions

Choledocholithiasis

Interventions

Group A - Stent exchange if cholecystectomy dated beyond 3 monthsPROCEDURE

Stent removal and cholangiogram and stone clearance (if recurrent stone/s is/are found). Stent exchange if cholecystectomy dated beyond 3 months

Group B - Diagnostic EUS/MRCP/USG abdomen and LFT at 3 monthsDIAGNOSTIC_TEST

Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months to see recurrence of CDL. ERC and stone clearance (if recurrent stone/s found on EUS/MRCP/USG abdomen)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 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.

Time frame: 3 Months

To compare the biliary complications between the 2 groups

Time frame: 3 Months

Data from ClinicalTrials.gov

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