Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis (STONE)

Asian Institute of Gastroenterology, India

Status: Not yet enrolling

Conditions: Choledocholithiasis

Treatments: Procedure: Group A - Stent exchange if cholecystectomy dated beyond 3 months; Diagnostic Test: Group B - Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months

Study type: Interventional

Funder types: Other

Identifiers

NCT06060002

STONE_1

Details and patient eligibility

About

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

Full 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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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480 participants in 2 patient groups

Group A - Patients will undergo stent removal and cholangiogram at 3 months of follow up

Active Comparator group

Description:

In group A, patients will undergo stent removal and cholangiogram at 3 months of follow up. If we detect recurrent stone/s on cholangiogram, clearance will be done accordingly. If the patient is dated for cholecystectomy beyond 3 months then stent exchange will be done and patient will be followed up till they undergo cholecystectomy. During this waiting period in the later group, patients will undergo monthly follow up for development of any new onset symptoms that are suggestive of biliary pain, pancreatitis, cholangitis and cholecystitis.

Treatment:

Procedure: Group A - Stent exchange if cholecystectomy dated beyond 3 months

Group B - Patients will undergo endoscopic ultrasound (EUS) at 3 months of follow up.

Sham Comparator group

Description:

In group B, patients will undergo endoscopic ultrasound (EUS) at 3 months of follow up. If we detect recurrent stone/s in EUS then ERC and clearance will be done accordingly. Those who are dated for cholecystectomy beyond 3 months will undergo monthly follow up clinically (biliary pain, pancreatitis, cholangitis and cholecystitis) till they undergo cholecystectomy. Those patient in group B who are unwilling for EUS will be requested to get an magnetic resonance cholangiopancreatography (MRCP) while those unwilling for both EUS/MRCP will be followed up with ultrasound abdomen and liver function test (LFT).

Treatment:

Diagnostic Test: Group B - Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months