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Timing of CHolecystectomy In Severe PAncreatitis

NCT06113419 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2025-09-15

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy will be performed using the standard American 4-port technique, insufflation will be achieved using CO2 to 15mmHg of pressure. Calot's triangle will be dissected until the critical view of safety is reached, being careful to dissect above the R4U line. After reaching the critical view of safety, two proximal and one distal clip will be placed on both the cystic conduct and artery separately, cutting the clips and then dissecting the gallbladder in a cystfundic direction. When the critical view of safety is not reached, the surgeon may perform a fundus-first cholecystectomy, subtotal cholecystectomy, conversion to open procedure, intraoperative cholangiography or cholecystostomy to their own discretion. It will also be the surgeon's criteria to employ or not a drain system in the surgical site. The decision for theses interventions will be taken intraoperatively and will be according to findings during the procedure.

Sponsors & Collaborators

  • Universidad del Rosario

    collaborator OTHER

  • Hospital Universitario Mayor Méderi

    lead OTHER

Principal Investigators

  • Camilo Ramirez-Giraldo, MD · Hospital Universitario Mayor Méderi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2027-01-31
Completion
2027-06-30

Countries

  • Colombia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06113419 on ClinicalTrials.gov