Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): study protocol for a randomized controlled trial

Camilo Ramírez-Giraldo, Danny Conde Monroy, José Alejandro Daza Vergara, Andrés Isaza-Restrepo, Isabella Van-Londoño, Luisa Trujillo-Guerrero

Research output: Contribution to journalArticlepeer-review

Abstract

Acute pancreatitis is the recurrent reason for gastrointestinal admission in a clinical urgent setting, it happens secondary to a wide array of pathologies out of which biliary disease stands as one of the most frequent causes for its presentation. Approximately 20% of pancreatitis are of moderate or severe severity. Currently, there is not a clear recommendation on timing for cholecystectomy, either early or delayed. CHISPA is a randomized controlled, parallel-group, superior clinical trial. An intention-to-treat analysis will be performed. It seeks to evaluate differences between patients taken to early cholecystectomy during hospital admission (72 hours after randomization) versus delayed cholecystectomy (30±5 days after randomization). The primary endpoint is major complications associated with laparoscopic cholecystectomy defined as a Clavien-Dindo score of over III/V during the first 90 days after the procedure. Secondary endpoints include recurrence of biliary disease, minor complications (Clavien-Dindo score below III/V), days of postoperative hospital stay, and length of stay in an intensive therapy unit postoperatively (if it applies). The CHISPA trial has been designed to demonstrate that delayed laparoscopic cholecystectomy reduces the rate of complications associated to an episode of severe biliary pancreatitis compared to early laparoscopic cholecystectomy.Trial registration number: NCT06113419.

Original languageEnglish
Article numbere000246
JournalBMJ Surgery, Interventions, and Health Technologies
Volume6
Issue number1
DOIs
StatePublished - 7 Mar 2024

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