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
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
Promoteur : Assistance Publique - Hôpitaux de Paris
Titre et résumé fournis en anglais par le registre source, reproduits sans traduction ni interprétation.
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.
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