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

Обзор

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.

Вмешательства

• Устройство 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.
• Другое 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

Первичные конечные точки

• evaluate the effectiveness of the Endorotor PED® device versus conventional technique for the endoscopic management of symptomatic walled-off necrosis during necrotizing acute pancreatitis. [Срок оценки: 5 month]

Вторичные конечные точки (12)

• number of death [Срок оценки: 10 month]
• number of new-onset multiple organ failure [Срок оценки: 10 month]
• number of visceral perforation [Срок оценки: 10 month]
• number of arterial perforation [Срок оценки: 10 month]
• number of pancreatic-cutaneous fistulas [Срок оценки: 10 month]
• number of sepsis [Срок оценки: 10 month]
• number of abscess [Срок оценки: 4 month]
• number of Bleeding of any severity [Срок оценки: 4 month]
• number of Need for surgery (video-assisted retroperitoneal debridement or open surgery) [Срок оценки: 4 month]
• number of Need for "multigate" strategy with the installation of a percutaneous drain [Срок оценки: 4 month]
• time to total recovery of acute pancreatitis [Срок оценки: 16 month]
• Total time of all DEN sessions in minutes [Срок оценки: 4 month]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Hospital Beaujon, APHP — Clichy

Идентификаторы

NCT: NCT07253350 · APHP230816 · ID-RCB

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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