Timing of CHolecystectomy in Severe PAncreatitis

Not Applicable

Recruiting

• Conditions: Acute Pancreatitis; Cholelithiasis
• Interventions: Procedure: Laparoscopic cholecystectomy

• Registration Number: NCT06113419
• Lead Sponsor: Hospital Universitario Mayor Méderi

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Study Start: 2024-04-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2026-05
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 134

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early cholecystectomy	Laparoscopic cholecystectomy	Early laparoscopic cholecystectomy (within 72 hours after randomization)
Interval cholecystectomy	Laparoscopic cholecystectomy	Interval laparoscopic cholecystectomy (30 +/- 5 days after randomization).

Primary Outcome Measures

Name	Time	Method
Major complications (rates)	90 days	Clavien-Dindo score V in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

Secondary Outcome Measures

Name	Time	Method
Minor complications (rates)	90 days	Clavien-Dindo score I-II in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Recurrence (rates)	90 days	Biliary disease recurrence defined as a new admission for recurrent pancreatitis, cholecystitis, cholangitis, choledocholithiasis, need fro ERCP or biliary colic previous to the surgical procedure until 90 postoperative days after it
Mortality (rates)	90 days	Determine differences in mortality between patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Postoperative hospital stay length (days; median)	90 days	Compare differences in postoperative hospital stay length (general) in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy
Postoperative stay length in the ICU (days; median)	90 days	Compare differences in postoperative stay length in the ICU in patients with moderately severe and severe acute pancreatitis of biliary origin taken to early vs interval cholecystectomy

Trial Locations

Locations (2)

Hospital Universitario Mayor-Méderi; 🇨🇴 Bogota, Cundinamarca, Colombia

Hospital Universitario Méderi Barrios Unidos; 🇨🇴 Bogota, Cundinamarca, Colombia