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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTokyo University

About this trial

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.

Eligibility criteria

Qualifiers

Patients diagnosed with necrotizing pancreatitis according to the revised Atlanta classification, confirmed by contrast-enhanced CT (plain CT or MRI may be substituted if contrast-enhanced CT is not feasible).

Within 28 days of onset of acute pancreatitis.

Age ≥ 18 years at the time of consent, regardless of sex.

Provided written informed consent from the patient or a legally authorized representative after sufficient explanation.

Disqualifiers

Unknown date of onset of acute pancreatitis.

Patients who have already undergone transluminal drainage with stent placement for necrotizing pancreatitis.

Diagnosis of chronic pancreatitis.

Patients for whom endoscopic treatment is deemed unsafe.

Trial design

Treatments tested in this trial

  • The timing of endoscopic intervention for necrotizing pancreatitis is determined based on the degree of encapsulation
  • EUS-guided drainage based on the interval from the onset of acute pancreatitis

Treatment groups

224 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tokyo University

Lead sponsor

Tokyo Women's Medical University

Sponsor institution

Tokyo Women's Medical University

Collaborator