Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis

Choledocholithiasis Clinical Trial

— STONE  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06060002
• Other study ID #: STONE_1
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: September 2023
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Choledocholithiasis
• Recurrence

Intervention

Procedure:
• Group A - Stent exchange if cholecystectomy dated beyond 3 months
Stent removal and cholangiogram and stone clearance (if recurrent stone/s is/are found). Stent exchange if cholecystectomy dated beyond 3 months

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the CDL recurrence rate between the 2 groups		3 Months
Secondary	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
Secondary	To compare the biliary complications between the 2 groups		3 Months