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NCT Number: NCT07517627

Optimal Timings of Laparoscopic Cholecystectomy After ERCP in Patients With Gallstones Along With CBD Stones

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

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Key information

Age range

14 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Laparoscopic Cholecystectomy

Procedure

Laparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy

Delayed Laparoscopic cholecystectomy

Procedure

Laparoscopic removal of gall bladder 2 weeks or more after successful ERCP

Primary outcomes

  1. Mean Operative time

    Time frame: During surgery

    Duration of surgery measured from the first incision to closure of the last incision.

Secondary outcomes

  1. Length of Hospital Stay

    Time frame: From admission to discharge (up to 30 days)

    Total number of days from hospital admission to discharge.

  2. Intraoperative Blood Loss

    Time frame: During Surgery

    Blood loss measured in milliliters from suction apparatus during surgery.

  3. Conversion to Open Cholecystectomy

    Time frame: During Surgery

    Number of patients requiring conversion from laparoscopic to open surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Muhammad Imran Anwar, FCPS, FRCS

CONTACT

[email protected]

+92 300 9442600

Dr. Rija Zainab, MS General surgery

CONTACT

[email protected]

+92-304-4050582

Sponsors and collaborators

Lead sponsor

Rija Zainab

Other

Collaborators

  • Shaikh Zayed Hospital, Lahore

Registry information

Official study title

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

Acronym: ED-LC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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