Actively Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Led by Hospital Universitario Mayor Méderi · Updated on 2025-09-15
134
Participants Needed
2
Research Sites
165 weeks
Total Duration
On this page
Sponsors
H
Hospital Universitario Mayor Méderi
Lead Sponsor
U
Universidad del Rosario
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Timing of CHolecystectomy In Severe PAncreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with diagnosis of pancreatitis according to Atlanta guidelines
- Moderately severe or severe pancreatitis (APACHE score 8 or higher on admission)
- Biliary pancreatitis confirmed by imaging (ultrasound, MRI, or CT)
- Recovered pancreatitis defined as tolerance of oral intake for 24 hours without vomiting and pain less than 4/10 on visual analogue score
- Provided written informed consent
You will not qualify if you...
- Pregnancy
- History of previous cholecystectomy
- Planned open cholecystectomy
- Pancreatitis complications before laparoscopic cholecystectomy (compartment syndrome, bleeding, or need for peripancreatic drainage)
- Chronic pancreatitis
- More than one episode of pancreatitis
- Active malignant disease
- Septic shock
- Unresolved choledocholithiasis after ERCP, post-ERCP perforation, or post-ERCP pancreatitis
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Universitario Mayor-Méderi
Bogota, Cundinamarca, Colombia, 111221
Actively Recruiting
2
Hospital Universitario Méderi Barrios Unidos
Bogota, Cundinamarca, Colombia, 111221
Actively Recruiting
Research Team
C
Camilo Ramírez-Giraldo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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