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Study identifier: NCT07253350 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Effectiveness of Endorotor PED® System Versus Conventional Endoscopic Techniques for the Management of Walled-off Pancreatic Necrosis in Acute Necrotizing Pancreatitis: Randomized Single-blinded Controlled Superiority Trial and Cost-utility Analysis

Condition: Acute Necrotizing Pancreatitis  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhaseNA
Planned participants64
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a national single-blinded prospective multicenter randomized (1:1) controlled trial, with two parallel arms, using a PROBE methodology, including patients with complicated acute necrotizing pancreatitis who require DEN of WON collection after endoscopic drainage. We will compare 2 groups: conventional DEN and DEN with Endorotor®. The study will be offered to all consecutive patients fulfilling the eligibility criteria after endoscopic drainage for WON. Since the time between drainage and the first necrosectomy session is usually at least 48 hours a period of at least 24h will be allowed for the patient to consider options to participate or not. Information and collection of informed consent will be done by an investigating physician.

This description comes directly from the study's public registry record.

Talk to the study team

Frederic Prat, MD PHD  ·  01 40 87 56 63  ·  frederic.prat@aphp.fr

Diane Lorenzo, MD PHD  ·  01 40 87 56 63  ·  diane.lorenzo@gmail.com

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital Beaujon, APHPClichy, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT07253350