Immediate Necrosectomy vs. Step-up Approach After EUS-guided Drainage of Walled-off Necrosis: a Multicenter Randomized Controlled Trial (WONDER-01)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 22
- 主要终点
- Time to clinical success from randomization
研究概览
简要总结
Walled-off necrosis (WON) is a pancreatic fluid collection, which contains necrotic tissue after four weeks of the onset of acute pancreatitis. Interventions are required to manage patients with infected WON, for which endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality. For patients who are refractory to EUS-guided drainage, the step-up treatment including endoscopic necrosectomy (EN) and/or additional drainage is considered to subside the infection. Recent evidence suggests that EN immediately after EUS-guided drainage may shorten treatment duration without increasing adverse events. In this randomized trial, the investigators will compare treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
详细描述
Pancreatic fluid collection is a late complication of severe acute pancreatitis. According to the revised Atlanta classification, walled-off necrosis (WON) is defined as an encapsulated collection of necrotic tissue that is observed after four weeks of the onset of acute pancreatitis. Infected WON is associated with high morbidity and mortality; therefore, an appropriate treatment, including antibiotics and drainage, is mandatory. With the development of endoscopic equipment, endoscopic ultrasonography (EUS)-guided drainage has become a first-line treatment modality for infected WON. For patients who are refractory to EUS-guided drainage, endoscopic necrosectomy (EN) is a treatment option to facilitate direct removal of infected necrotic tissue within the WON. However, due to potentially lethal adverse events of EN, such as bleeding, perforation, and peritonitis, EN is usually withheld for several days after EUS-guided drainage. This strategy is known as "the step-up approach." Recently, with the accumulated evidence supporting the safety of EN, especially with the use of a dedicated lumen-apposing metal stent, it has been reported that EN immediately after EUS-guided drainage can shorten the treatment duration without increasing adverse events. Given these lines of evidence, the investigators hypothesized that immediate EN following EUS-guided drainage of WON might shorten time to clinical success compared to the step-up approach. To examine this hypothesis, the investigators planned to conduct a multicenter randomized controlled trial comparing treatment duration between EN immediately after EUS-guided drainage versus the step-up approach in patients with symptomatic WON.
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
- None
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 WON defined according to the revised Atlanta classification
- •The longest diameter of WON is 4 cm or larger
- •Patients with at least one out of the following conditions; signs of infection, gastrointestinal symptoms, abdominal symptoms, obstructive jaundice
- •Patients who need drainage for WON
- •Age of 18 years or older
- •Patients or their representatives provide informed consent
- •Patients who visit or are hospitalized at the participating institutions
排除标准
- •WON inaccessible by EUS-guided approach
- •AXIOS stent has already been placed into the WON prior to the enrollment
- •Severe coagulopathy; Platelet count < 50,000/mm3 or prothrombin time international normalized ratio (PT-INR) >1.5
- •Patients on antithrombotic agents which cannot be managed according to the "guideline for gastroenterological endoscopy in patients undergoing antithrombotic treatment (Dig Endosc. 2014 Jan;26(1):1-14.)"
- •Patients who cannot tolerate endoscopic procedures
- •Pregnant women
- •Patients considered inappropriate for inclusion by investigators
结局指标
主要结局
Time to clinical success from randomization
时间窗: Six months
Clinical success is defined as 1) a decrease in the WON size to 3 cm or less and 2) an improvement of more than two out of the three following inflammatory markers; body temperature, white blood cell count, and C-reactive protein.
次要结局
- New onset of pseudocyst(Five years)
- Number and time of interventions(Six months)
- Recurrence of WON(Five years)
- Treatment duration of recurrent WON(Five years)
- The presence and timing of sarcopenia(Five years)
- Technical success rate of initial EUS-PCD (Endoscopic ultrasonography-guided pseudocyst drainage)(One day)
- Incidence of biliary and gastrointestinal stricture(Five years)
- Indwelling time of endoscopic and percutaneous drainage(Six months)
- Duration of antibiotics administration(Six months)
- Treatment duration of new onset pseudocyst(Five years)
- Cost of interventions and hospital stay(Six months)
- Incidence of new onset diabetes, clinical symptoms of pancreatic exocrine insufficiency, and pancreatic cancer(Five years)
- The presence and timing of medications for pancreatic exocrine insufficiency(Five years)
- Time to recurrence of WON(Five years)
- Adverse events(Five years)
- Mortality(Five years)
- Morphological change of pancreas(Five years)
- Success rate and operation time of surgical procedures(Six months)
- Hospital stay and ICU stay(Six months)
研究者
Yousuke Nakai
Associate professor, Department of Endoscopy and Endoscopic Surgery, The University of Tokyo Hospital
Tokyo University