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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Colombia
Hospital Universitario Mayor-Méderi
RECRUITING
Bogota
Hospital Universitario Méderi Barrios Unidos
RECRUITING
Bogota
Contact Information
Primary
Camilo Ramírez-Giraldo, MD
ramirezgiraldocamilo@gmail.com
+5773206770474
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-06
Participants
Target number of participants: 134
Treatments
Experimental: Early cholecystectomy
Early laparoscopic cholecystectomy (within 72 hours after randomization)
Active_comparator: Interval cholecystectomy
Interval laparoscopic cholecystectomy (30 +/- 5 days after randomization).
Sponsors
Collaborators: Universidad del Rosario
Leads: Hospital Universitario Mayor Méderi

This content was sourced from clinicaltrials.gov