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

NCT07517627 | Recruiting DMC

• 1 other identifier: TERC/FB/INT/595/2024
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholelithiasis Associated With Common Bile Duct Stones

Outcome Measures

Primary Outcomes (1)

• Mean Operative time

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

  During surgery

Secondary Outcomes (3)

• Length of Hospital Stay

  From admission to discharge (up to 30 days)

• Intraoperative Blood Loss

  During Surgery

• Conversion to Open Cholecystectomy

  During Surgery

Study Arms (2)

Early laparoscopic cholecystectomy

EXPERIMENTAL

Patients will undergo laparoscopic cholecystectomy within 72hours followed by successful ERCP

Procedure: Early laparoscopic cholecystectomy

Delayed Laparoscopic cholecystectomy

ACTIVE COMPARATOR

Patients will undergo laparoscopic cholecystectomy 2 weeks or more after successful ERCP

Procedure: Delayed Laparoscopic cholecystectomy

Interventions

Early laparoscopic cholecystectomy PROCEDURE

Laparoscopic removal of gall bladder within 72hours of laparoscopic cholecystectomy

Early laparoscopic cholecystectomy

Delayed Laparoscopic cholecystectomy PROCEDURE

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

Delayed Laparoscopic cholecystectomy

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Rija Zainab: lead
• Shaikh Zayed Hospital, Lahore: collaborator

Study Sites (1)

Shaikh Zayed hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Study Officials

• Dr. Rija Zainab, MS General surgery

  Shaikh Zayed Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Rija Zainab, MS General surgery

CONTACT

+92-304-4050582; rijazainab09@gmail.com

Dr. Muhammad Imran Anwar, FCPS, FRCS

CONTACT

+92 300 9442600; imran_anwar21@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Postgraduate Resident, Department of General Surgery, Sheikh Zayed Hospital, Lahore

Model Details: Parallel Assignment (Two arms, Early vs Delayed Laparoscopic cholecystectomy)

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: April 8, 2026
• Study Start: May 5, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

PA (1)