Preventing Recurrent 'Idiopathic' Acute Pancreatitis Through Laparoscopic Cholecystectomy (PICUS-2): a Multicenter Randomized Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Netherlands
Amsterdam UMC, location University of Amsterdam
RECRUITING
Amsterdam
Contact Information
Primary
Michiel F.G. Francken, MD
m.f.g.francken@amsterdamumc.nl
+31 088-320-7052
Time Frame
Start Date: 2023-07-30
Estimated Completion Date: 2026-07-30
Participants
Target number of participants: 262
Treatments
Experimental: Laparoscopic cholecystectomy
Active_comparator: Watchful waiting
Sponsors
Leads: M.G. Besselink

This content was sourced from clinicaltrials.gov