Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2)
PICUS-2
1 other identifier
interventional
262
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 30, 2023
CompletedFirst Submitted
Initial submission to the registry
January 30, 2024
CompletedFirst Posted
Study publicly available on registry
April 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2026
ExpectedApril 30, 2024
April 1, 2024
2 years
January 30, 2024
April 29, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Acute pancreatitis recurrence
Acute pancreatitis recurrence, irrespective of etiology
Within 1 year after date of inclusion
Study Arms (2)
Laparoscopic cholecystectomy
EXPERIMENTALWatchful waiting
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- At least 18 years old
- Eligible for early (laparoscopic)\* cholecystectomy
- Full required diagnostic work-up of patient has been performed, including EUS
- First episode of 'EUS-negative' IAP
- Informed consent for participation was obtained \*if required open cholecystectomy is allowed
You may not qualify if:
- Recurrent acute pancreatitis
- Diagnosis of chronic pancreatitis
- Diagnosis of necrotizing pancreatitis
- Current pancreatic malignancy
- Prior cholecystectomy
- Documented etiology of acute pancreatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.G. Besselinklead
Study Sites (1)
Amsterdam UMC, location University of Amsterdam
Amsterdam, North Holland, 1081 HV, Netherlands
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD PhD
Study Record Dates
First Submitted
January 30, 2024
First Posted
April 30, 2024
Study Start
July 30, 2023
Primary Completion
July 30, 2025
Study Completion (Estimated)
July 30, 2026
Last Updated
April 30, 2024
Record last verified: 2024-04