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Immediate Necrosectomy vs. Step-up Approach for Walled-off Necrosis

Study acronym: WONDER-01
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 27, 2022 (before its estimated April 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Start date changed from estimate of Jul 11, 2022 to Jul 29, 2022v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 1, 2022 to Jul 11, 2022
    • Site details revised at 21 of 21 sites
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and/or additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
Trial Details
NCT Number NCT05451901
Lead Sponsor Tokyo University
Conditions
(from sponsor)		 Pancreatic Fluid Collection, Walled-off Necrosis, Pancreatitis, Acute Necrotizing, Pancreatic Pseudocyst
Related terms Pancreatic Pseudocyst, Pancreatitis, Acute Necrotizing
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov