Preventing recurrent *idiopathic* acute pancreatitis through laparoscopic cholecystectomy (PICUS-2): a multicenter randomized trial
Recruiting
- Conditions
- idiopathic pancreatitisinflammation of the pancreas with an unknown origin1001796910017998
- Registration Number
- NL-OMON53591
- Lead Sponsor
- Amsterdam UMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 220
Inclusion Criteria
1. Patient older than 18 years
2. First episode of idiopathic acute pancreatitis
3. Full required diagnostic work-up of patient has been performed, including EUS
4. Informed consent for participation was obtained
Exclusion Criteria
1. Patients with recurrent acute pancreatitis
2. Diagnosis of chronic pancreatitis
3. Patients with a pancreatic malignancy
4. Patients who have received a laparoscopic cholecystectomy prior to PICUS-2
5. Patients in whom a known etiology is found during diagnostic work-up
6. Patients in whom complete diagnostic work-up by EUS is not possible (eg.
Roux-en-y bypass)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure for this trial is a confirmed recurrent acute<br /><br>pancreatitis (irrespective of the aetiology of recurrent pancreatitis) within<br /><br>one year from the date of randomization</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary outcome measures for this trial are<br /><br>- Readmission for one or more of the following reasons: Recurrent pancreatitis;<br /><br>Cholecystitis; Cholangitis; Obstructive choledocholithiasis needing endoscopic<br /><br>retrograde cholangiopancreatography; Gallstone colic.<br /><br><br /><br>- Complications of LC: Bile duct injury and bleeding; Requiring the need for<br /><br>additional surgical endoscopic, or radiological intervention; infection; Other<br /><br>complications such as pneumonia, bacteremia, and new-onset organ failure.<br /><br><br /><br>- Number and severity of recurrent episodes of pancreatitis<br /><br><br /><br>- Quality of life (QALY)<br /><br><br /><br>- Costs (hospital and societal)<br /><br><br /><br>- Cost-effectiveness</p><br>