Status:
RECRUITING
Timing of CHolecystectomy In Severe PAncreatitis
Lead Sponsor:
Hospital Universitario Mayor Méderi
Collaborating Sponsors:
Universidad del Rosario
Conditions:
Acute Pancreatitis
Cholelithiasis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
CHISPA is a randomized controlled, parallel-group, superiority clinical trial. An intention- to-treat analysis will be performed. It seeks to evaluate differences between patients taken to early chole...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT06113419
Start Date
April 1 2024
End Date
June 1 2027
Last Update
September 15 2025
Active Locations (2)
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1
Hospital Universitario Mayor-Méderi
Bogota, Cundinamarca, Colombia, 111221
2
Hospital Universitario Méderi Barrios Unidos
Bogota, Cundinamarca, Colombia, 111221