Conventional Endoscopic Techniques Versus EndoRotor® System for Necrosectomy of Walled of Necrosis

Официальное название

A Prospective, Post-Market, Multicenter, Randomized Controlled Trial to Compare the Performance of the EndoRotor® System Versus Conventional Endoscopic Techniques for Direct Endoscopic Necrosectomy of Walled Off Necrosis - The RESOlVE Trial

Обзор

In acute pancreatitis, approximately 20% of the cases result in severe necrotizing pancreatitis which is associated with significant morbidity and mortality. Necrotizing pancreatitis is characterized by the development of an acute necrotic collection and as this collection persists beyond 4 weeks, walled off necrosis (WON) encapsulates the collection. To date, this is treated by the step-up approach, which contains percutaneous drainage and minimally invasive video assisted retroperitoneal debridement (VARD) or endoscopic ultrasound (EUS) guided drainage followed by direct endoscopic necrosectomy (DEN). Different DEN techniques are available for the treatment of WON, however, there is a lack of effective endoscopic instruments to perform DEN. Recently, the first dedicated alternative to conventional DEN has been cleared for use, namely the EndoRotor® Resection System. This device is a powered mechanical debridement device intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. Previous (pilot and feasibility) studies showed promising results in terms of the amount of procedures, adverse events and length of hospital stay. Therefore, aim of this study is to assess the performance of the EndoRotor, as compared to conventional endoscopic techniques, for direct endoscopic necrosectomy (DEN) of walled off necrosis (WON) in a randomized controlled trial.

Вмешательства

• Устройство EndoRotor® System (Interscope, Inc., Northbridge, MA USA),
  The EndoRotor System is intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. DEN with the EndoRotor System (study device) is considered to be standard of care therapy for patients with WON and not investigational.
• Процедура Conventional endoscopic devices (according to standards of care)
  Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference.

Первичные конечные точки

• The number of DEN procedures required to achieve resolution of WON [Срок оценки: During a 6 month follow up period]

Вторичные конечные точки (9)

• Adverse events [Срок оценки: During a 6 month follow up period]
• Conversion to surgery defined as number of subject that require surgical intervention as a result of DEN failure as assessed by the Investigator during the index procedure through the 6 month post necrosectomy follow-up visit [Срок оценки: During a 6 month follow up period]
• Length of hospitalization [Срок оценки: During a 6 month follow up period]
• Mean total cost of care per subject [Срок оценки: During a 6 month follow up period]
• Percent reduction in WON collection volume (cm3) [Срок оценки: During a 6 month follow up period]
• Procedure time [Срок оценки: During a 6 month follow up period]
• Debridement time [Срок оценки: During a 6 month follow up period]
• Subject Quality of Life [Срок оценки: During a 6 month follow up period]
• The number of device deficiencies, defined as any inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance including malfunction, use errors, and inadequate labelingprocedure [Срок оценки: During a 6 month follow up period]

Критерии участия

Критерии включения

• Patients with symptomatic pancreatic necrosis due to acute pancreatitis that have an indication to undergo endoscopic necrosectomy after having undergone EUS-guided drainage.

a. Stent must be in place for a minimum of 2 days prior to the DEN procedure.

• Patients who can tolerate repeat endoscopic procedures.
• Subjects with the ability to understand the requirements of the study, who have provided written informed consent, and who are willing and able to return for the required follow-up assessments.
• ASA classification < 5.

Критерии исключения

• Documented pseudoaneurysm > 1 cm within the WON.
• Subject unable or unwilling to provide informed consent.
• Intervening gastric varices or unavoidable blood vessels within the WON access tract (visible using endoscopy or endoscopic ultrasound).
• Coagulation disorders or anti-coagulant therapy which cannot be discontinued (aspirin allowed).
• Any condition that in the opinion of the Investigator would create an unsafe clinical situation or stent placement that would not allow the patient to safely undergo an endoscopic procedure.
• Pregnant or lactating women or women of childbearing potential who do not employ a reliable method of contraception as judged by the Investigator, and/or are not willing to use reliable contraception for the duration of study participation.
• Patient is enrolled in another trial that could interfere with the endpoint analyses of this trial.
• Prior necrosectomy on existing collection.
• Greater than 2 pancreatic / extra-pancreatic fluid collections.

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

США · 3 центра

• University of Alabama Medical Center — Birmingham
• California Pacific Medical Center — San Francisco
• Thomas Jefferson University Hospital — Philadelphia

Нидерланды · 3 центра

• Charlotte van Veldhuisen — Amsterdam
• Amsterdam University Medical Center — Amsterdam
• St. Antonius Hospital — Nieuwegein

Германия · 2 центра

• Evangelical Hospital — Düsseldorf
• University of Frankfurt — Frankfurt

Италия · 2 центра

• Humanitas Reserach Hospital & Humanitas University — Milan
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma

Дания · 1 центр

• Copenhagen University Hospital — Hvidovre

Великобритания · 1 центр

• Central Manchester University Hospital — Manchester

Идентификаторы

NCT: NCT04814693 · CLIN-0061

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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