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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 16
- 主要终点
- The number of DEN procedures required to achieve resolution of WON
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The number of DEN procedures required to achieve resolution of WON
时间窗: During a 6 month follow up period
1. Resolution is defined as clinical improvement of WON symptoms precluding the need for additional endoscopic or surgical interventions. 2. Clinical improvement is defined according to the criteria used in the PANTER trial and TENSION trial.8,15 "Clinical improvement" was defined as: i. Improved function of at least two organ systems (i.e. circulatory, pulmonary, renal) according to the Investigator's medical judgement within 72 hours, or; ii. At least 10% improvement of two out of three parameters of infection (i.e. C-reactive protein, leucocyte count or temperature) within 72 hours.
次要结局
- Length of hospitalization(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(During a 6 month follow up period)
- Procedure time(During a 6 month follow up period)
- Adverse events(During a 6 month follow up period)
- Subject Quality of Life(During a 6 month follow up period)
- Mean total cost of care per subject(During a 6 month follow up period)
- Percent reduction in WON collection volume (cm3)(During a 6 month follow up period)
- Debridement time(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(During a 6 month follow up period)
研究者
Marco J. Bruno
Prof. Marco Bruno
Erasmus Medical Center