Timing of CHolecystectomy In Severe PAncreatitis — CHISPA  

Acute Pancreatitis Clinical Trial

Official title: Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): Study Protocol for a Randomized Controlled Trial.

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

CHISPA is a randomized controlled, parallel-group, superiority 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). Primary endpoint is major complications associated to 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, mortality, minor complications (Clavien-Dindo score below III/V), days of postoperative hospital stay, and days admitted in an intensive care unit postoperatively. ;

Related Conditions & MeSH terms

• Acute Pancreatitis
• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Pancreatitis

• NCT number: NCT06113419
• Study type: Interventional
• Source: Hospital Universitario Mayor Méderi
• Contact: Camilo Ramírez-Giraldo, MD
• Phone: +5773206770474
• Email: ramirezgiraldocamilo@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2024
• Completion date: December 2026