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NCT Number: NCT07253350

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

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.

    Time frame: 5 month

    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.

Secondary outcomes

  1. number of death

    Time frame: 10 month

  2. number of new-onset multiple organ failure

    Time frame: 10 month

  3. number of visceral perforation

    Time frame: 10 month

  4. number of arterial perforation

    Time frame: 10 month

  5. number of pancreatic-cutaneous fistulas

    Time frame: 10 month

  6. number of sepsis

    Time frame: 10 month

  7. number of abscess

    Time frame: 4 month

  8. number of Bleeding of any severity

    Time frame: 4 month

  9. number of Need for surgery (video-assisted retroperitoneal debridement or open surgery)

    Time frame: 4 month

  10. number of Need for "multigate" strategy with the installation of a percutaneous drain

    Time frame: 4 month

  11. time to total recovery of acute pancreatitis

    Time frame: 16 month

  12. Total time of all DEN sessions in minutes

    Time frame: 4 month

  13. Total number of DEN sessions

    Time frame: 4 month

  14. Number of days of antibiotic treatment

    Time frame: 4 month

  15. operative difficulty of DEN assessed by endoscopists

    Time frame: 4 month

    A Likert score will be used to assess the ease of use to maneuver device by endoscopist, from 0 (most difficult surgery imaginable) to 10 (easiest).

  16. number of issues with Endorotor PED® device

    Time frame: 4 month

    Failure types and number of occurrences

  17. Number of days of hospitalization: In intensive care unit

    Time frame: 16 month

  18. Number of days of hospitalization: In conventional unit

    Time frame: 16 month

  19. Number of days of hospitalization in rehabilitation unit

    Time frame: 16 month

  20. quality of life of patients during and after hospitalization

    Time frame: 16 month

    EQ-5D-5L score at the end of hospitalization and during follow-up's visits

  21. Total hospital costs in acute care per patient Endorotor

    Time frame: 16 month

Study contacts

Contact information is provided by the study sponsor or research team.

Diane Lorenzo, MD PHD

CONTACT

[email protected]

01 40 87 56 63 ext. +33

Frederic Prat, MD PHD

CONTACT

[email protected]

01 40 87 56 63 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: ROTONEC

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 28, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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