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.
Age≥18years
ASA<5
CT scan less than 7 days old
Hospitalized for acute necrotizing pancreatitis, whatever the cause, and who have undergone drainage of pancreatic collections for the following indications according to the revised Atlanta criteria (infection, organ compression, persistent organ failure)
No endoscopic drainage in place for the management of WON
Have already had a DEN session (endoscopic or else) before screening for inclusion
Life-expectancy < 1year (advanced cancer, etc)
Known haemostasis disorder (chronic thrombocytopenia, haemophilia, etc.)
Parallel
Endorotor Group
DeviceDEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy. Endorotor 3.2 is slimmer and enters WON more easily when the transgastric access is located in the upper portion of the stomach). If needed: lavage, aspiration and conventional mechanical debridement could be used in addition during an ENDOROTOR-based DEN session.
Conventional group
Other interventionDEN is performed conventionally with abundant lavage and mechanical debridement using a non-dedicated material (diathermic loop, polypectomy or Dormia basket) to catch pieces of necrosis
evaluate the effectiveness of the Endorotor PED® device versus conventional technique for the endoscopic management of symptomatic walled-off necrosis during necrotizing acute pancreatitis.
The effectiveness of the operative approach (Endorotor 3.2/PED® or conventional technique) will be assessed by the period in days between the first DEN session and the confirmed complete necrosis resolution.
number of death
number of new-onset multiple organ failure
number of visceral perforation
number of arterial perforation
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