Endoscopic Large Caliber Drainage vs. Complete Necrosectomy for Treatment of Walled-off Pancreatic Necrosis: A Prospective, Randomized Noninferiority Trial.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 主要终点
- Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)
研究概览
简要总结
The purpose of this study is to determine optimal treatment strategies for symptomatic walled-off pancreatic necrosis( 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (> 18 yo) patients
- •With symptomatic walled- off pancreatic necrosis in which an endoscopic approach is appropriate based on cross-sectional imaging
- •Must have solid necrotic material present in their pancreatic fluid collection as determined by MRI, EUS, or direct transluminal endoscopic imaging of the collection
排除标准
- •Previous intervention for pancreatic necrosis (surgical, percutaneous, or endoscopic)
- •Indication for emergency laparotomy (compartment syndrome, bowel ischemia, bleeding, or perforation of a GI lumen)
- •Uncorrectable coagulopathy.
研究组 & 干预措施
Greater than 50% Necrosis
Subjects who have greater than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
干预措施: Double Pigtail Plastic Stent (Device)
Greater than 50% Necrosis
Subjects who have greater than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
干预措施: AXIOS Metal Stent (Device)
Less than 50% Necrosis
Subjects who have less than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
干预措施: Double Pigtail Plastic Stent (Device)
Less than 50% Necrosis
Subjects who have less than 50% necrosis as determined by MRI, Endoscopic Ultrasound (EUS), or direct transluminal endoscopic imaging of the collection. This stratification group will be randomized to either the double pigtail plastic stent or the AXIOS metal stent.
干预措施: AXIOS Metal Stent (Device)
结局指标
主要结局
Complete resolution as defined by complete radiographic resolution of the walled-off necrosis (WON)
时间窗: Baseline to 4 months after initiation of endoscopic treatment
次要结局
- Decrease in total costs of pancreatitis-related health care during treatment course(Baseline to 4 months after initiation of endoscopic treatment)
- Clinical resolution of infection as defined by complete radiographic resolution and/or symptoms of pain and gastric outlet obstruction(Baseline to 4 months after initiation of endoscopic treatment)
- Decrease in incidence of adverse events(Baseline to 4 months after initiation of endoscopic treatment)
- Symptom resolution (Visual Analogue Scale for pain, gastric outlet obstruction, and weight gain)(Baseline to 4 months after initiation of endoscopic treatment)
- Decrease in number of hospital days during treatment course(Baseline to 4 months after initiation of endoscopic treatment)
研究者
Barham K. Abu Dayyeh, M.D.
Principal Investigator
Mayo Clinic