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Timing of CHolecystectomy In Severe PAncreatitis

RecruitingNAAges 18 Years - anyAllHospital Universitario Mayor Méderi
NCT06113419 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 panc

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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What it tests

  • Laparoscopic cholecystectomy
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Where

2 sites
Hospital Universitario Mayor-Méderi
Bogota, Colombia
Hospital Universitario Méderi Barrios Unidos
Bogota, Colombia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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