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

NCT ID: NCT06391359

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 262 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-30
• Study Completion Date: 2026-07-30

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.

Conditions

Idiopathic Acute Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Laparoscopic cholecystectomy

Group Type: EXPERIMENTAL

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Laparoscopic cholecystectomy

Watchful waiting

Group Type: ACTIVE_COMPARATOR

Watchful waiting

Intervention Type: OTHER

Watchful waiting

Interventions

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy

Intervention Type: PROCEDURE

Watchful waiting

Watchful waiting

Intervention Type: OTHER

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 episode of 'EUS-negative' IAP
• Informed consent for participation was obtained *if required open cholecystectomy is allowed

Exclusion Criteria

• Recurrent acute pancreatitis
• Diagnosis of chronic pancreatitis
• Diagnosis of necrotizing pancreatitis
• Current pancreatic malignancy
• Prior cholecystectomy
• Documented etiology of acute pancreatitis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

M.G. Besselink

OTHER

Sponsor Role: lead

Responsible Party

M.G. Besselink

Professor, MD PhD

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Amsterdam UMC, location University of Amsterdam

Amsterdam, North Holland, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Michiel F.G. Francken, MD

Role: CONTACT

m.f.g.francken@amsterdamumc.nl

+31 088-320-7052

Other Identifiers

NL82531.018.23

Identifier Type: -

Identifier Source: org_study_id