NCT02440724Unknown不适用
The Usefulness of Self-expandable Metal Stents(SEMS) for Malignant Gastric Outlet Obstruction: a Prospective Study Using New Designed Stents
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Complication rate(stent migration and tumor ingrowth) of new designed winged stent
研究概览
简要总结
The purpose of this study is to evaluate usefulness of new designed winged stent(SEMS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastric outlet obstruction symptom
- •Diagnosis of gastric outlet obstruction by radiologist or endoscopist
- •Gastric outlet obstruction by malignant disease
- •Aged over 19
- •Informed consent
排除标准
- •Gastric outlet obstruction by benign disease or infectious disease
- •Could not endoscopic intervention by poor general condition
- •Refusal of patient
研究组 & 干预措施
winged stent group
Experimental
participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).
干预措施: Winged stent (partially covered) (Device)
winged stent group
Experimental
participants who are assigned to winged-stent group will be treated with deployment of a winged stent(partially covered or uncovered SEMS).
干预措施: Winged stent (uncovered) (Device)
结局指标
主要结局
Complication rate(stent migration and tumor ingrowth) of new designed winged stent
时间窗: up to 16 weeks from stent insertion
It will be assessed by a composite measure consisting of physical exam, ECOG PS, GOOSS and gastrointestinal imaging.
次要结局
- Evaluate the clinical success rate of SEMS insertion(up to 16 weeks from stent insertion)
- Evaluate the technical success rate of SEMS insertion(up to 16 weeks from stent insertion)
- Difference of insertion time between previous stent insertion and new designed stent(1 years)
研究者
Ji Yong Ahn
Assistant Professor
Asan Medical Center
研究点 (1)
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