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

NCT06391359 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 262

Last updated 2024-04-30

No results posted yet for this study

Summary

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 episode of 'EUS-negative' IAP.

Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization.

Study population: Adults with a first episode of 'EUS-negative' IAP.

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.

Conditions

  • Idiopathic Acute Pancreatitis

Interventions

PROCEDURE

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy

OTHER

Watchful waiting

Watchful waiting

Sponsors & Collaborators

  • M.G. Besselink

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-07-30
Primary Completion
2025-07-30
Completion
2026-07-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06391359 on ClinicalTrials.gov