Endorotor versus standard endoscopic removal for walled-off pancreatic necrosis
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
NA · Assistance Publique - Hôpitaux de Paris · NCT07253350
This trial will try whether using the Endorotor device helps adults with infected or symptomatic walled-off pancreatic necrosis recover faster or with fewer procedures than standard endoscopic necrosectomy after drainage.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Clichy) |
| Trial ID | NCT07253350 on ClinicalTrials.gov |
What this trial studies
This is a national, single-blinded, multicenter randomized (1:1) trial using a PROBE design that enrolls adults with complicated acute necrotizing pancreatitis who require direct endoscopic necrosectomy (DEN) after endoscopic drainage of walled-off necrosis (WON). Participants are randomized to conventional DEN or DEN using the Endorotor system, with outcomes including clinical recovery, number of necrosectomy sessions, complications, and cost-utility. Informed consent is obtained after at least 24 hours of consideration following a minimum 48-hour interval from drainage to the first necrosectomy session. The trial compares procedural effectiveness and resource use between the two approaches across participating French centers.
Who should consider this trial
Good fit: Adults (≥18 years) hospitalized for acute necrotizing pancreatitis who have undergone endoscopic drainage for infected or symptomatic WON and still require at least one DEN session are ideal candidates.
Not a fit: Patients without an endoscopic drainage in place, those who already had a necrosectomy before screening, people with limited life expectancy, known major bleeding disorders, or who are pregnant will not benefit or are ineligible.
Why it matters
Potential benefit: If successful, the Endorotor approach could reduce the number of necrosectomy sessions, shorten hospital stays, lower complication rates, and decrease overall treatment costs.
How similar studies have performed: Small case series and nonrandomized reports of powered endoscopic necrosectomy devices have shown promising results, but randomized controlled evidence directly comparing Endorotor to conventional DEN is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Clichy
- Hospital Beaujon, APHP — Clichy, France (RECRUITING)
Study contacts
- Principal investigator: frederic Prat, MD PHD — APHP
- Study coordinator: Frederic Prat, MD PHD
- Email: frederic.prat@aphp.fr
- Phone: 01 40 87 56 63
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Acute Necrotizing Pancreatitis, endoscopic necrosectomy, necrotic pancreatic collection