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

NCT07253350 | Recruiting

• 2 other identifiers: APHP230816ID-RCB
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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

Keywords

endoscopic necrosectomy; necrotic pancreatic collection

Outcome Measures

Primary Outcomes (1)

• 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.

  5 month

Secondary Outcomes (21)

• number of death

  10 month

• number of new-onset multiple organ failure

  10 month

• number of visceral perforation

  10 month

• number of arterial perforation

  10 month

• number of pancreatic-cutaneous fistulas

  10 month

Study Arms (2)

Endorotor Group

EXPERIMENTAL

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

Device: Endorotor Group

Conventional group

ACTIVE COMPARATOR

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

Other: Conventional group

Interventions

Endorotor Group 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.

Endorotor Group

Conventional group 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

Conventional group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• No endoscopic drainage in place for the management of WON
• 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
• Subject already involved in another interventional clinical research

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hospital Beaujon, APHP

Clichy, France

RECRUITING

MeSH Terms

Conditions

Pancreatitis, Acute Necrotizing

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases

Study Officials

• frederic Prat, MD PHD

  APHP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frederic Prat, MD PHD

CONTACT

01 40 87 56 63; frederic.prat@aphp.fr

Diane Lorenzo, MD PHD

CONTACT

01 40 87 56 63; diane.lorenzo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: November 28, 2025
• Study Start: January 20, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: January 30, 2026

Record last verified: 2026-01

Locations

FR (1)