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Recruiting NCT07517627

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

No phase Interventional Cholelithiasis Associated With Common Bile Duct Stones

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Early laparoscopic cholecystectomy, Delayed Laparoscopic cholecystectomy.
Who it may be relevant to
Registry conditions: Cholelithiasis Associated With Common Bile Duct Stones. Basic parameters: 14 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

  • Procedure Early laparoscopic cholecystectomy
    Laparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy
  • Procedure Delayed Laparoscopic cholecystectomy
    Laparoscopic removal of gall bladder 2 weeks or more after successful ERCP

Primary outcome measures

  • Mean Operative time [Time frame: During surgery]
Secondary outcome measures (3)
  • Length of Hospital Stay [Time frame: From admission to discharge (up to 30 days)]
  • Intraoperative Blood Loss [Time frame: During Surgery]
  • Conversion to Open Cholecystectomy [Time frame: During Surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Shaikh Zayed hospital Lahore — Lahore

Identifiers

NCT: NCT07517627 · TERC/FB/INT/595/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗