Comparing early versus delayed gallbladder surgery in severe pancreatitis
Timing of CHolecystectomy In Severe PAncreatitis (CHISPA): Study Protocol for a Randomized Controlled Trial.
This study is testing whether having gallbladder surgery right after being hospitalized for severe pancreatitis is better than waiting about a month to see if it leads to fewer complications and a quicker recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitario Mayor Méderi Academic / other |
| Locations | 2 sites (Bogota, Cundinamarca and 1 other locations) |
| Trial ID | NCT06113419 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the outcomes of early laparoscopic cholecystectomy performed within 72 hours of hospitalization against interval cholecystectomy scheduled approximately 30 days after recovery from pancreatitis. It will evaluate major complications using the Clavien-Dindo classification, alongside secondary outcomes such as minor complications, recurrence of biliary disease, mortality rates, and length of hospital stay. Participants will be randomly assigned to one of the two surgical timing groups, and an intention-to-treat analysis will be conducted to assess the effectiveness of each approach.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with moderately severe or severe pancreatitis and biliary pancreatitis confirmed by imaging.
Not a fit: Patients with chronic pancreatitis, active malignant disease, or those who have had previous gallbladder surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced complications for patients with severe pancreatitis requiring gallbladder removal.
How similar studies have performed: Previous studies have explored surgical timing in pancreatitis, but this specific comparison of early versus interval cholecystectomy is less common, making it a potentially novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bogota, Cundinamarca and 1 other locations
- Hospital Universitario Mayor-Méderi — Bogota, Cundinamarca, Colombia (Recruiting)
- Hospital Universitario Méderi Barrios Unidos — Bogota, Cundinamarca, Colombia (Recruiting)
Study contacts
- Principal investigator: Camilo Ramirez-Giraldo, MD — Hospital Universitario Mayor Méderi
- Study coordinator: Camilo Ramírez-Giraldo, MD
- Email: ramirezgiraldocamilo@gmail.com
- Phone: +5773206770474
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.