Timing of CHolecystectomy In Severe PAncreatitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario Mayor Méderi

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Pregnancy

History of cholecystectomy

Planned open cholecystectomy

Pancreatitis-associated complication before laparoscopic cholecystectomy (compartment syndrome, bleeding and/or need for peripancreatic collection drainage)

Trial design

Treatments tested in this trial

  • Laparoscopic cholecystectomy

Treatment groups

134 Participants
are divided into 2 treatment groups

Locations

2

Map coordinates are unavailable for these locations. Locations are shown below instead.

Hospital Universitario Mayor-MéderiRecruiting111221, Bogota, CundinamarcaColombiaColombia
Hospital Universitario Méderi Barrios UnidosRecruiting111221, Bogota, CundinamarcaColombiaColombia

Sponsors and collaborators

Hospital Universitario Mayor Méderi

Lead sponsor

Universidad del Rosario

Collaborator