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

NCT ID: NCT07253350

Last Updated: 2026-01-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-20
• Study Completion Date: 2029-11-30

Brief Summary

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.

Conditions

Acute Necrotizing Pancreatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Endorotor Group

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

Group Type: EXPERIMENTAL

Endorotor Group

Intervention Type: DEVICE

DEN 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

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

Group Type: ACTIVE_COMPARATOR

Conventional group

Intervention Type: OTHER

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

Interventions

Endorotor Group

DEN 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.

Intervention Type: DEVICE

Conventional group

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

frederic Prat, MD PHD

Role: PRINCIPAL_INVESTIGATOR

APHP

Locations

Hospital Beaujon, APHP

Clichy, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Frederic Prat, MD PHD

Role: CONTACT

frederic.prat@aphp.fr

01 40 87 56 63 ext. +33

Diane Lorenzo, MD PHD

Role: CONTACT

diane.lorenzo@gmail.com

01 40 87 56 63 ext. +33

Facility Contacts

Frederic Prat, MD PHD

Role: primary

frederic.prat@aphp.fr

01 40 87 56 63 ext. +33

Other Identifiers

ID-RCB

Identifier Type: OTHER

Identifier Source: secondary_id

APHP230816

Identifier Type: -

Identifier Source: org_study_id