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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Endorotor Group, Conventional group.
- Who it may be relevant to
- Registry conditions: Acute Necrotizing Pancreatitis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Endorotor Group
DEN will be performed with Endorotor 3.2 or ENDOROTOR PED® system depending on the position of cystoenterostomy. Endorotor 3.2 is slimmer and enters WON more easily when the transgastric access is located in the upper portion of the stomach). If needed: lavage, aspiration and conventional mechanical debridement could be used in addition during an ENDOROTOR-based DEN session. - Other Conventional group
DEN is performed conventionally with abundant lavage and mechanical debridement using a non-dedicated material (diathermic loop, polypectomy or Dormia basket) to catch pieces of necrosis
Primary outcome measures
- evaluate the effectiveness of the Endorotor PED® device versus conventional technique for the endoscopic management of symptomatic walled-off necrosis during necrotizing acute pancreatitis. [Time frame: 5 month]
Secondary outcome measures (12)
- number of death [Time frame: 10 month]
- number of new-onset multiple organ failure [Time frame: 10 month]
- number of visceral perforation [Time frame: 10 month]
- number of arterial perforation [Time frame: 10 month]
- number of pancreatic-cutaneous fistulas [Time frame: 10 month]
- number of sepsis [Time frame: 10 month]
- number of abscess [Time frame: 4 month]
- number of Bleeding of any severity [Time frame: 4 month]
- number of Need for surgery (video-assisted retroperitoneal debridement or open surgery) [Time frame: 4 month]
- number of Need for "multigate" strategy with the installation of a percutaneous drain [Time frame: 4 month]
- time to total recovery of acute pancreatitis [Time frame: 16 month]
- Total time of all DEN sessions in minutes [Time frame: 4 month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hospital Beaujon, APHP — Clichy
Identifiers
NCT: NCT07253350 · APHP230816 · ID-RCB