NCT01839292已完成不适用
A Newly Designed Conformable Uncovered Versus Covered Self-expandable Metallic Stent for Palliation of Malignant Gastric Outlet Obstruction: a Prospective, Randomized Multicenter Study
Ajou University School of Medicine2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2010年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- the stent patency time from stent insertion to restenosis due to stent malfunction or death
研究概览
简要总结
Covered self-expandable metallic stents (SEMS) have been used to prevent tumor ingrowth, a common complication of uncovered SEMSs. However, they have revealed a high incidence of stent migration in patients with unresectable malignant gastric outlet obstruction (GOO). A conformable covered SEMS was introduced to overcome both stent migration and tumor ingrowth. The aims of this study were to evaluate the clinical outcomes of newly designed conformable covered and uncovered SEMS for palliation of malignant GOO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •adults 18 years of age or older
- •obstructive symptoms due to unresectable malignant GOO
- •a Karnofsky performance score of more than 30 (13)
排除标准
- •history of a previous SEMS insertion
- •the presence of obstruction in the gastrointestinal tract excluding the gastric outlet
- •severe comorbidities precluding the endoscopic procedure, such as cardiopulmonary disease, sepsis, and bleeding disorders
- •a life expectancy of less than 1 month after SEMS insertion
- •history of gastric surgery
结局指标
主要结局
the stent patency time from stent insertion to restenosis due to stent malfunction or death
时间窗: Up to 1 years
次要结局
- stent malfunction (e.g., stent migration or occlusion due to tumor ingrowth/overgrowth) and the reintervention rate(up to 1 years)
研究者
Sun Gyo Lim
Assistant professor
Ajou University School of Medicine
研究点 (2)
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