About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.)
Trial design
Treatments tested in this trial
- Endorotor Group
- Conventional group