idiopathic pancreatitis inflammation of the pancreas with an unknown origin
Conditions
Interventions
The intervention of this study is a laparoscopic cholecystectomy performed
within four weeks of the first episode of idiopathic acute pancreatitis or
during initial admission.
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: At least 18 years oldEligible for early cholecystectomyFull required diagnostic work-up of patient has been performed, including EUSFirst, second or third episode of IAP, in which at least one episode characterized by a negative EUS result has been reportedInformed consent for participation was obtained
Exclusion criteria
Exclusion criteria: 1. Patients with more than 3 episodes of idiopathic 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure for this trial is a confirmed recurrent acute pancreatitis (irrespective of the aetiology of recurrent pancreatitis) within one year from the date of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures for this trial are - Readmission for one or more of the following reasons: Recurrent pancreatitis; Cholecystitis; Cholangitis; Obstructive choledocholithiasis needing endoscopic retrograde cholangiopancreatography; Gallstone colic. - Complications of LC: Bile duct injury and bleeding; Requiring the need for additional surgical endoscopic, or radiological intervention; infection; Other complications such as pneumonia, bacteremia, and new-onset organ failure. - Number and severity of recurrent episodes of pancreatitis - Quality of life (QALY) - Costs (hospital and societal) - Cost-effectiveness | — |
Countries
China, Germany, Hungary, Italy, Netherlands, Norway, Spain, Sweden
Contacts
Public ContactR.B. Schwarz
Amsterdam UMC
Outcome results
None listed