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 (ROTONEC)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Acute Necrotizing Pancreatitis

Treatments: Device: Endorotor Group; Other: Conventional group

Study type: Interventional

Funder types: Other

Identifiers

NCT07253350

APHP230816

ID-RCB (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)
• Have need for at least one DEN session despite endoscopic drainage (persistence of clinical symptoms or sepsis >48h after drainage with collection still visible)

Exclusion criteria

• 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.)
• Pregnant or breastfeeding woman
• Subject deprived of freedom, subject under a legal protective measure
• Non-affiliation to a social security regimen or CMU
• Patient or person of confidence (if present at the time of inclusion) opposing the patient's participation in research
• Subject already involved in another interventional clinical research

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Endorotor Group

Experimental group

Description:

DEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy.

Treatment:

Device: Endorotor Group

Conventional group

Active Comparator group

Description:

DEN 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

Treatment:

Other: Conventional group