Clinical Trial

Timing of CHolecystectomy In Severe PAncreatitis

Study acronym: CHISPA
Recruiting
View on ClinicalTrials.gov →
Summary
The goal of this clinical trial is to compare outcomes for interval or early laparoscopic cholecystectomy in patients with moderately severe and severe pancreatitis. The main question\[s\] it aims to answer are: * To establish whether there is a difference in surgical outcomes comparing patients diagnosed with severe or moderately severe pancreatitis on which early cholecystectomy was performed versus performing interval cholecystectomy. * The primary endpoint will be to evaluate major complications, defined as a Clavien-Dindo score greater than or equal to III/V. * Secondary endpoints include evaluating minor complications (defined as a Clavien-Dindo score below III/V), biliary disease recurrence, mortality, postoperative hospital stay and postoperative admittance into an intensive care unit. Participants will be randomly assigned to either group: early cholecystectomy during the pancreatitis hospitalization or interval cholecystectomy scheduled 4 weeks after clinical resolution of pancreatitis.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-10-27; most recent amendment 2025-09-09.
Status change: Not Yet Recruiting → Recruiting 2025-03-14
Trial Details
NCT Number NCT06113419
Lead Sponsor Hospital Universitario Mayor Méderi
Collaborators: Universidad del Rosario
Conditions Acute Pancreatitis, Cholelithiasis
Enrollment 134 participants
Start Date 2024-04-01
Primary Completion 2027-01 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2025-09-15