Comparing early versus delayed gallbladder surgery in severe pancreatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the outcomes of early laparoscopic cholecystectomy performed within 72 hours of hospitalization against interval cholecystectomy scheduled approximately 30 days after recovery from pancreatitis. It will evaluate major complications using the Clavien-Dindo classification, alongside secondary outcomes such as minor complications, recurrence of biliary disease, mortality rates, and length of hospital stay. Participants will be randomly assigned to one of the two surgical timing groups, and an intention-to-treat analysis will be conducted to assess the effectiveness of each approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years, diagnosis of pancreatitis according to Atlanta guidelines, moderately severe or severe pancreatitis (APACHE score ≥8 on admittance)
* Biliary pancreatitis diagnosed on imaging (be it ultrasound, magnetic resonance imaging and/or tomography)
* Recovery of pancreatitis by tolerance of oral intake (defined as 24 hours of food consumption of any consistency without emetic episodes and pain defined as 4/10 on the visual analogue score of pain) and written informed consent.

Exclusion Criteria:

* Pregnancy
* History of cholecystectomy
* Planned open cholecystectomy
* Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage)
* Chronic pancreatitis,
* More than one episode of pancreatitis
* Active malignant disease
* Septic shock
* Choledocholithiasis not resolved by ERCP, post-ERCP perforation and post-ERCP concomitant pancreatitis.

Where it's running

• Hospital Universitario Mayor-Méderi
  Bogota, Cundinamarca, Colombia Recruiting
• Hospital Universitario Méderi Barrios Unidos
  Bogota, Cundinamarca, Colombia Recruiting

Study contacts

• Principal investigator: Camilo Ramirez-Giraldo, MD — Hospital Universitario Mayor Méderi
• Study coordinator: Camilo Ramírez-Giraldo, MD
• Email: ramirezgiraldocamilo@gmail.com
• Phone: +5773206770474

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.