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
| NCT ID | NCT07253350 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Acute Necrotizing Pancreatitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2026-01-20 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2026-01-20 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
frederic Prat, MD PHD
PRINCIPAL INVESTIGATOR
APHP
Frequently Asked Questions
Who can join the NCT07253350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Necrotizing Pancreatitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07253350 currently recruiting?
Yes, NCT07253350 is actively recruiting participants. Contact the research team at frederic.prat@aphp.fr for enrollment information.
Where is the NCT07253350 trial being conducted?
This trial is being conducted at Clichy, France.
Who is sponsoring the NCT07253350 clinical trial?
NCT07253350 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is frederic Prat, MD PHD at APHP. The trial plans to enroll 64 participants.