STONE: Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis

Sponsor

Asian Institute of Gastroenterology, India (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06060002

Collaborator

(none)

480

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Choledocholithiasis	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	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

480 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Diagnostic

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)

Anticipated Study Start Date :

Sep 30, 2023

Anticipated Primary Completion Date :

Dec 30, 2025

Anticipated Study Completion Date :

Dec 30, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A - Patients will undergo stent removal and cholangiogram at 3 months of follow up 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.	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
Sham Comparator: Group B - Patients will undergo endoscopic ultrasound (EUS) at 3 months of follow up. 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).	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)

Arm

Intervention/Treatment

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

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.

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

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

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).

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)

Outcome Measures

Primary Outcome Measures

To compare the CDL recurrence rate between the 2 groups [3 Months]

Secondary Outcome Measures

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]
To compare the biliary complications between the 2 groups [3 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Asian Institute of Gastroenterology, India

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Asian Institute of Gastroenterology, India

ClinicalTrials.gov Identifier:

NCT06060002

Other Study ID Numbers:

STONE_1

First Posted:

Sep 29, 2023

Last Update Posted:

Sep 29, 2023

Last Verified:

Sep 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Choledocholithiasis

Recurrence

Study Results

No Results Posted as of Sep 29, 2023