NCT02084537已完成不适用
Minimally Invasive Surgery vs. Endoscopy Randomized (MISER) Trial for Necrotizing Pancreatitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AdventHealth
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Major complications
研究概览
简要总结
Prospective, randomized controlled trial comparing Endoscopic Ultrasound (EUS) Guided cystogastrostomy or cystoduodenostomy and endoscopic necrosectomy to minimally invasive surgical necrosectomy, in patients with necrotizing pancreatitis.
详细描述
Patients will be randomly allocated to either treatment arm in a 1:1 ratio. Following intervention, patients will be assessed at regular intervals until study completion at 6 months post-discharge. Primary outcome is a composite of major complications and/or mortality, measured to 6 months post-discharge.
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
- •Necrotic collection
- •Infected (suspected and confirmed): clinical signs of infection (septic, positive cultures, febrile), systemic inflammatory response syndrome, gas within the collection on imaging (not iatrogenic), or positive culture of collection contents
- •Necrotic collection is within 15mm of the lumen of the gastrointestinal tract.
- •18 years and older
- •Informed consent obtained from the patient or their medical representative.
- •Medically fit for general anesthetic
- •Collection amenable to either endoscopic or minimally invasive surgical necrosectomy and drainage.
排除标准
- •<18 years old
- •Unable to obtain informed consent from the patient or their medical representative.
- •Medically unfit for general anesthesia
- •Necrotic collection not accessible by either or both techniques
- •The collection is >15mm from the lumen of the gastrointestinal tract.
- •Irreversible coagulopathy: International Normalized Ratio (INR) >1.5
- •Irreversible thrombocytopenia: platelet count <50 x10^9/L
- •Dual antiplatelet therapy or therapeutic anticoagulation that cannot be withheld for the procedure
- •Surgical or endoscopic necrosectomy or pseudocyst drainage has been performed within the preceding 12 months
- •Necrotic collection secondary to trauma or other surgical event that requires additional interventions such as management of liver lacerations or vascular injury.
- •Pre-existing percutaneous drain
结局指标
主要结局
Major complications
时间窗: 6 months post discharge
Composite of major complications and/or mortality (all cause and disease specific), measured to 6 months post discharge
次要结局
未报告次要终点
研究者
研究点 (2)
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