Timing of CHolecystectomy In Severe PAncreatitis
Recruiting now · Not applicable
Conditions studied: Acute Pancreatitis, Cholelithiasis
In brief
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.
Key facts
- Study ID
- NCT06113419
- Run by
- Hospital Universitario Mayor Méderi
- People needed
- 134
- Starts
- 2024-04-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2025-09-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hospital Universitario Mayor-Méderi — Bogota, Cundinamarca, Colombia (enrolling)
- Hospital Universitario Méderi Barrios Unidos — Bogota, Cundinamarca, Colombia (enrolling)
Full record on ClinicalTrials.gov
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