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

Primary Purpose

Choledocholithiasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Group A - Stent exchange if cholecystectomy dated beyond 3 months
Group B - Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months
Sponsored by
Asian Institute of Gastroenterology, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Choledocholithiasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

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

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

    Arm 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.

    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).

    Outcomes

    Primary Outcome Measures

    To compare the CDL recurrence rate between the 2 groups

    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.
    To compare the biliary complications between the 2 groups

    Full Information

    First Posted
    September 13, 2023
    Last Updated
    September 27, 2023
    Sponsor
    Asian Institute of Gastroenterology, India
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06060002
    Brief Title
    Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis
    Acronym
    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)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 30, 2023 (Anticipated)
    Primary Completion Date
    December 30, 2025 (Anticipated)
    Study Completion Date
    December 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Asian Institute of Gastroenterology, India

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Choledocholithiasis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    480 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A - Patients will undergo stent removal and cholangiogram at 3 months of follow up
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Group B - Patients will undergo endoscopic ultrasound (EUS) at 3 months of follow up.
    Arm Type
    Sham Comparator
    Arm 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).
    Intervention Type
    Procedure
    Intervention Name(s)
    Group A - Stent exchange if cholecystectomy dated beyond 3 months
    Intervention Description
    Stent removal and cholangiogram and stone clearance (if recurrent stone/s is/are found). Stent exchange if cholecystectomy dated beyond 3 months
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Group B - Diagnostic EUS/MRCP/USG abdomen and LFT at 3 months
    Intervention Description
    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)
    Primary Outcome Measure Information:
    Title
    To compare the CDL recurrence rate between the 2 groups
    Time Frame
    3 Months
    Secondary Outcome Measure Information:
    Title
    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
    Title
    To compare the biliary complications between the 2 groups
    Time Frame
    3 Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Learn more about this trial

    Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis

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