Actively Recruiting
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
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-01-30
64
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- ASA score less than 5
- CT scan performed less than 7 days before enrollment
- Hospitalized for acute necrotizing pancreatitis regardless of cause
- Have undergone drainage of pancreatic collections due to infection, organ compression, or persistent organ failure
- Require at least one DEN session after endoscopic drainage due to persistent symptoms or sepsis over 48 hours with visible collection
You will not qualify if you...
- No endoscopic drainage currently in place for WON management
- Have already undergone a DEN session before screening
- Life expectancy less than 1 year due to conditions like advanced cancer
- Known bleeding disorders such as chronic thrombocytopenia or hemophilia
- Pregnant or breastfeeding women
- Individuals deprived of freedom or under legal protection
- Not affiliated with a social security system or CMU
- Patient or legal representative opposes participation
- Already participating in another interventional clinical trial
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Beaujon, APHP
Clichy, France
Actively Recruiting
Research Team
F
Frederic Prat, MD PHD
CONTACT
D
Diane Lorenzo, MD PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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