Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis

NCT06060002 | Unknown

• 1 other identifier: STONE_1
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

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

Conditions

Choledocholithiasis

Outcome Measures

Primary Outcomes (1)

• To compare the CDL recurrence rate between the 2 groups

  3 Months

Secondary Outcomes (2)

• 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

Study Arms (2)

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

ACTIVE COMPARATOR

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

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

SHAM COMPARATOR

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

Interventions

Group A - Stent exchange if cholecystectomy dated beyond 3 months PROCEDURE

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

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

Group B - Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months DIAGNOSTIC_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)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18-80 years
• Cases of cholelithiasis with concomitant CDL in whom CBD clearance is achieved will be included.

You may not qualify if:

• 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

Sponsors & Collaborators

• Asian Institute of Gastroenterology, India: lead

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 29, 2023
• Study Start: September 30, 2023
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 29, 2023

Record last verified: 2023-09