Endoscopic Gastroenteric Anastomosis Formed by Magnetic Compression and Stent Placement for Palliation of Malignant Gastric Outlet Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent
研究概览
简要总结
The purpose of this study is to determine if the Cook Magnetic Anastomosis Device can be used to safely and successfully create a patent gastrojejunal anastomosis in subjects requiring treatment of gastric outlet obstruction caused by malignancy.
详细描述
Surgical treatments for malignant gastric outlet obstructions carry substantial risks and are associated with postoperative morbidity. External compression from advancing tumor or tissue growth through the stent can cause stenosis or re-obstruction. In these patients, the creation of a patent fistula that allows gastric emptying may significantly improve palliation. Minimally invasive techniques that carry no greater risks than enteral stenting may provide a viable palliative treatment. The primary objectives are safety, and successful creation of a gastro-jejunal anastomosis. Secondary objectives are successful resumption or improvement in the ability to tolerate PO feeding, rate of stent migration, and duration of stent and anastomosis patency.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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 unresectable malignancy with, or at risk of developing gastric outlet obstruction with GOOSS ≤ 2
- •Karnofsky Performance Score ≥ 60
排除标准
- •Patient is unable to understand and execute informed consent
- •Age below 18 years
- •Patients with any prior gastrointestinal surgery that significantly alters gastrojejunal anatomy
- •Implanted cardiac pacemaker, defibrillator or ventricular assist device
- •Requirement for chronic anticoagulation, or with uncorrectable coagulopathy
- •Patients receiving chronic steroids or other drugs that may impair wound healing or formation of an intact anastomosis
- •Simultaneously participating in another investigational drug or device
- •Patients with suspicion of, or documented multiple small bowel strictures
研究组 & 干预措施
1
palliative treatment of gastric outlet obstruction
干预措施: Cook Magnetic Anastomosis Device (MAD) with Stent (Device)
结局指标
主要结局
Success Rate Associated With the Creation of a Gastro-jejunal Anastomosis Using the Cook Magnetic Anastomosis Device With Trans-anastomotic Deployment of a Gastro-jejunal or Duodenal Stent
时间窗: Approximately 8-10 days
Success is defined as placement of the gastric and jejunal magnets, creation of the anastomosis, and deployment of the gastro-jejunal stent.
次要结局
未报告次要终点