Role of Prophylactic Biliary Stent in Reducing the Recurrence of Choledocholithiasis

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)

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06060002

Acronym

STONE

Enrollment

480

Registered

2023-09-29

Start date

2023-09-30

Completion date

2025-12-30

Last updated

2023-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Choledocholithiasis

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.

Interventions

PROCEDUREGroup 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_TESTGroup 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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
To compare the CDL recurrence rate between the 2 groups	3 Months

Secondary

Measure	Time frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026