Clinical Trial

Encapsulation-oriented vs. Timing-oriented Strategies for Necrotizing Pancreatitis

Study acronym: WONDER-03
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
This multicenter, randomized controlled trial (WONDER-03 study) investigates the optimal timing for endoscopic ultrasound (EUS)-guided drainage in patients with necrotizing pancreatitis. Although current guidelines recommend delaying drainage until at least four weeks after the onset of acute pancreatitis to allow for encapsulation of necrosis, recent observational data suggest that the degree of encapsulation itself may more strongly influence treatment success and safety. In this trial, patients are randomly assigned to one of two groups: an encapsulation-oriented group, in which EUS-guided drainage is performed when imaging confirms ≥80% encapsulation of the necrotic collection with symptoms, and a timing-oriented group, in which drainage is performed at four to five weeks after disease onset, regardless of encapsulation status. The primary endpoint is clinical success within 180 days, defined as both radiologic resolution of necrosis and improvement in symptoms. Secondary endpoints include adverse event rates, recurrence of fluid collections, technical and clinical success rates, and healthcare resource use. This study aims to determine whether a strategy based on encapsulation leads to better clinical outcomes than the conventional time-based approach and may help establish a new evidence-based treatment algorithm for necrotizing pancreatitis.
Trial Details
NCT Number NCT07106346
Lead Sponsor Tokyo University
Collaborators: Tokyo Women's Medical University
Conditions Walled Off Necrosis, Pancreatitis, Acute Necrotic Collection, Necrotizing Pancreatitis, Pancreatitis, Acute Necrotizing
Enrollment 224 participants
Start Date 2025-08-05
Primary Completion 2028-07-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-06