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Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)

RecruitingNAAges 18 Years - anyAllM.G. Besselink
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In plain words

What the trial is, and whether it could suit you

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 w

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Laparoscopic cholecystectomy
  • Watchful waiting
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Where

1 site
Amsterdam UMC, location University of Amsterdam
Amsterdam, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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