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Compares treatment options for Acute Necrotizing Pancreatitis
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
ClinicalTrials.gov ID: NCT07253350
What this study is testing
- What it's testing
- 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®.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Have need for at least one DEN session despite endoscopic drainage (persistence of clinical symptoms or sepsis \>48h after drainage with collection...
You likely can't join if
- 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
See the full eligibility 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...
- Have need for at least one DEN session despite endoscopic drainage (persistence of clinical symptoms or sepsis \>48h after drainage with collection still visible)
- 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 treatment clinical research
The study team makes the final eligibility decision.
Where it's taking place
- Clichy, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Clichy, France. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.