Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laparoscopic cholecystectomy, Watchful waiting.
- Who it may be relevant to
- Registry conditions: Idiopathic Acute Pancreatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2): a Multicenter Randomized Trial
Overview
Rationale: Annually, acute pancreatitis is diagnosed in 6,500 patients in the Netherlands. In up to 25% of patients no definitive cause can be determined after routine work-up including endoscopic ultrasound and this is deemed to be idiopathic acute pancreatitis (IAP). IAP is known for its high recurrence rate. It is hypothesized that microlithiasis, a type of biliary pancreatitis, is the most common cause of IAP. Laparoscopic cholecystectomy (LC) is highly effective in preventing recurrence of biliary pancreatitis. Currently no randomized trial has compared LC with conservative treatment in patients with IAP after adequate work-up including endoscopic ultrasound. Objective: To assess the effectiveness of LC as compared to conservative treatment in patients after a first, second or third episode of an 'EUS-negative' IAP. Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization. Study population: Adults with a first, second or third episode of IAP, of which at least one episode is characterized by a 'negative EUS'. Intervention (if applicable): Laparoscopic cholecystectomy versus conservative treatment. Main study parameters/endpoints: The primary endpoint is pancreatitis recurrence. Secondary endpoints include occurrence of biliary events, complications of LC, number and severity of recurrent episodes of pancreatitis, quality of life (QALY), costs (hospital and societal) and cost-effectiveness.
Interventions
- Procedure Laparoscopic cholecystectomy
Laparoscopic cholecystectomy - Other Watchful waiting
Watchful waiting
Primary outcome measures
- Acute pancreatitis recurrence [Time frame: Within 1 year after date of inclusion]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Amsterdam UMC, location University of Amsterdam — Amsterdam
Identifiers
NCT: NCT06391359 · NL82531.018.23