Preventing recurrent idiopathic acute pancreatitis with laparoscopic surgery
Official title: Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2): a Multicenter Randomized Trial
Run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · NCT06391359 · Data updated 2026-11-12
This study is testing if laparoscopic surgery to remove the gallbladder can help adults who had a first episode of unexplained acute pancreatitis avoid having it happen again, compared to just managing it with regular treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 262 (estimated) |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam, North Holland) |
| Status | Recruiting |
| Started | July 30, 2023 |
| Main results expected | July 30, 2027 |
| Study ends | July 30, 2028 |
| Registry record updated | August 3, 2026 |
| Trial ID | NCT06391359 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older who have had a first episode of 'EUS-negative' idiopathic acute pancreatitis and are eligible for laparoscopic cholecystectomy.
✕Probably not a fit
Patients with recurrent acute pancreatitis, chronic pancreatitis, or those with a documented etiology of their condition may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the effectiveness of laparoscopic cholecystectomy (LC) compared to conservative treatment in adults who have experienced a first episode of 'EUS-negative' idiopathic acute pancreatitis (IAP). The study will involve a multicenter randomized controlled design, where participants will be followed for one year after randomization to assess recurrence rates of pancreatitis. The hypothesis is that microlithiasis may be a common underlying cause of IAP, and that LC could significantly reduce the risk of recurrence. The trial is designed to fill a gap in current knowledge, as no prior randomized trials have compared these two treatment approaches in this patient population.
Why it matters
Potential benefit: If successful, this study could provide a definitive treatment option to prevent recurrent episodes of idiopathic acute pancreatitis.
How similar studies have gone: While this approach is novel in the context of idiopathic acute pancreatitis, laparoscopic cholecystectomy has shown success in preventing recurrence in biliary pancreatitis, suggesting potential for positive outcomes in this study.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years old * Eligible for early (laparoscopic)\* cholecystectomy * Full required diagnostic work-up of patient has been performed, including EUS * First, second or third episode of IAP, of which at least one episode characterized by a 'negative-EUS'' result * Informed consent for participation was obtained \*if required open cholecystectomy is allowed Exclusion Criteria: * Patients with more than 3 episodes of acute pancreatitis * Diagnosis of chronic pancreatitis * Diagnosis of necrotizing pancreatitis * Current pancreatic malignancy * Prior cholecystectomy * Documented etiology of acute pancreatitis
Where it's running
-
Amsterdam UMC, location University of Amsterdam
Amsterdam, North Holland, Netherlands Recruiting
Study contacts
- Study coordinator: Rolf R. B. Schwarz, MD
- Email: r.schwarz@amsterdamumc.nl
- Phone: +31 088-320-7052
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.