Best timing for laparoscopic gallbladder removal after ERCP
Comparative Analysis of Early Versus Delayed Laparoscopic Cholecystectomy After Endoscopic Retrograde Cholangiopancreatography (ERCP) in Patients of Cholelithiasis With Choledocholithiasis
This trial will see if removing the gallbladder within 72 hours after ERCP works better than waiting at least one month for people with gallstones and cleared common bile duct stones.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 14 Years to 70 Years |
| Sex | All |
| Sponsor | Shaikh Zayed Hospital, Lahore Academic / other |
| Locations | 1 site (Lahore, Punjab Province) |
| Trial ID | NCT07517627 on ClinicalTrials.gov |
What this trial studies
Patients with gallstones and confirmed common bile duct stones who have had successful ERCP stone clearance will be randomly assigned to early laparoscopic cholecystectomy (within 72 hours) or delayed cholecystectomy (one month or more). The trial will compare operative time, intra-operative blood loss, length of hospital stay, and rates of conversion to open surgery. It is a randomized controlled trial conducted at Shaikh Zayed Hospital, Lahore, enrolling adults and adolescents aged 14–70 with recent symptoms and duct clearance. Patients with imaging suggestive of malignancy or who develop severe pancreatitis after ERCP are excluded.
Who should consider this trial
Good fit: People aged 14–70 with symptomatic gallstones and confirmed common bile duct stones who had successful ERCP clearance and symptom duration under three days are the intended participants.
Not a fit: Patients with imaging signs of malignancy, those who develop severe post-ERCP pancreatitis, those without complete duct clearance, or those unfit for laparoscopy are unlikely to benefit from the early-versus-delayed comparison.
Why it matters
Potential benefit: If successful, doing the operation earlier could shorten operating time and hospital stay, reduce complications and conversions, and lower overall costs for patients.
How similar studies have performed: Previous randomized and observational studies generally suggest early laparoscopic cholecystectomy after ERCP can reduce recurrent biliary events and shorten hospital stay, though practices and results vary by center.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lahore, Punjab Province
- Shaikh Zayed hospital Lahore — Lahore, Punjab Province, Pakistan (Recruiting)
Study contacts
- Principal investigator: Dr. Rija Zainab, MS General surgery — Shaikh Zayed Hospital, Lahore
- Study coordinator: Dr. Rija Zainab, MS General surgery
- Email: rijazainab09@gmail.com
- Phone: +92-304-4050582
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.