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
Locations
2Map coordinates are unavailable for these locations. Locations are shown below instead.
Sponsors and collaborators
Hospital Universitario Mayor Méderi
Lead sponsor
Universidad del Rosario
Collaborator