Optimal Timings of Laparoscopic Cholecystectomy After ERCP in Patients With Gallstones Along With CBD Stones (ED-LC)

April 3, 2026 updated by: Rija Zainab

Comparative Analysis of Early Versus Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography (ERCP) in Patients of Cholelithiasis With Choledocholithiasis

This randomized controlled trial aims to compare the mean operative time and outcomes of early versus delayed laparoscopic cholecystectomy after ERCP in patients with cholelithiasis and choledocholithiasis. Patients will be randomized into two groups: early cholecystectomy (within 72 hours of ERCP) and delayed cholecystectomy (≥1 month after ERCP). Outcomes include operative time, intra-operative blood loss, hospital stay, and conversion to open cholecystectomy

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gallstones are among the most common surgical problems worldwide, and up to 20% of patients with gallstones also present with stones in the common bile duct. Standard care involves clearance of bile duct stones, typically by Endoscopic Retrograde Cholangiopancreaticography (ERCP), followed by removal of the gallbladder by laparoscopic cholecystectomy (LC).

The timing of cholecystectomy after ERCP remains debated. Early LC (within 72 hours) has been associated with fewer recurrent biliary events, reduced hospital stay, and potentially easier operative conditions. However, delayed LC (after one month) continues to be widely practiced due to institutional factors and scheduling constraints.

This randomized controlled trial at Sheikh Zayed Hospital, Lahore, is designed to evaluate whether early LC after ERCP offers measurable advantages compared with delayed LC. Patients with confirmed cholelithiasis and choledocholithiasis will be randomized into two groups: early surgery and delayed surgery. The trial will provide local evidence to guide surgical practice, focusing on operative efficiency and patient recovery.

By clarifying the optimal timing of LC after ERCP in our patient population, the study aims to support evidence-based surgical decision-making, improve outcomes, and potentially reduce healthcare costs.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54000
        • Recruiting
        • Shaikh Zayed hospital Lahore
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  • Patients diagnosed with cholelithiasis with choledocholithiasis based on clinical and radiological findings (right subcostal pain, presence of gallstones, and dilated common bile duct on ultrasound and MRCP)
  • Age 14 to 70 years
  • Both males and females
  • Duration of symptoms less than 3 days
  • Presence of common bile duct stone with successful clearance on ERCP

Exclusion Criteria

  • Features suggestive of malignancy on imaging
  • Patients who develop severe pancreatitis after ERCP

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early laparoscopic cholecystectomy
Patients will undergo laparoscopic cholecystectomy within 72hours followed by successful ERCP
Procedure: Early laparoscopic cholecystectomy
Laparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy
Active Comparator: Delayed Laparoscopic cholecystectomy
Patients will undergo laparoscopic cholecystectomy 2 weeks or more after successful ERCP
Procedure: Delayed Laparoscopic cholecystectomy
Laparoscopic removal of gall bladder 2 weeks or more after successful ERCP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Operative time
Time Frame: During surgery
Duration of surgery measured from the first incision to closure of the last incision.
During surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of Hospital Stay
Time Frame: From admission to discharge (up to 30 days)
Total number of days from hospital admission to discharge.
From admission to discharge (up to 30 days)
Intraoperative Blood Loss
Time Frame: During Surgery
Blood loss measured in milliliters from suction apparatus during surgery.
During Surgery
Conversion to Open Cholecystectomy
Time Frame: During Surgery
Number of patients requiring conversion from laparoscopic to open surgery
During Surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rija Zainab

Collaborators

Shaikh Zayed Hospital, Lahore

Investigators

  • Principal Investigator: Dr. Rija Zainab, MS General surgery, Shaikh Zayed Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 14, 2025

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • TERC/FB/INT/595/2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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