Endorotor versus standard endoscopic removal for walled-off pancreatic necrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pancreatic enzyme replacement for recovery after severe necrotizing pancreatitis

  This trial will test whether taking pancreatic enzyme capsules helps adults (18–60) with acute necrotizing pancreatitis who have lost at least 5% of their weight and have >50% pancreatic necrosis regain weight over three months compared with placebo.

  Recruiting at 4 sites Phase 3 Asian Institute of Gastroenterology, India · Guwahati, Assam and 3 other locations · NCT07441824

• Removing the spleen with open debridement for necrotizing pancreatitis and left-sided portal hypertension

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  Recruiting Zhejiang University · Hangzhou, Zhejiang · NCT07080697

• When to do endoscopic drainage for infected necrotizing pancreatitis

  We will test if earlier endoscopic drainage (within the first four weeks) helps adults with infected necrotizing pancreatitis recover faster and avoid complications.

  Recruiting Orlando Health, Inc. · Orlando, Florida · NCT07406698

• Comparing immediate necrosectomy to a step-up approach for treating walled-off necrosis

  This study is testing whether a quick procedure to remove walled-off necrosis can help people with symptoms from acute pancreatitis recover faster than the usual step-by-step treatment.

  Recruiting at 13 sites Tokyo University · Bunkyō-Ku, Tokyo and 20 other locations · NCT05451901

• Organ function changes after open necrosectomy for infected necrotizing pancreatitis with sepsis

  This project will see if organ function improves or worsens after open necrosectomy in adults with infected necrotizing pancreatitis and sepsis.

  Recruiting West China Hospital · Chengdu, China · NCT06380842

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.