Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction
试验速览
- 阶段
- 4 期
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- The patency rate at 8 weeks after placement.
研究概览
简要总结
Self-expandable metallic stents provide effective palliation of malignant gastric outlet obstruction. However, uncovered stent are often associated with re-stenosis caused by tumor in-growth through the stent mesh. The Self-expandable metallic stents which has the design of smaller wire mesh size (double bare stent) were developed and used in Korea. This new design was developed to minimize the re-stenosis of uncovered stent, but the outcome is unknown. The end point of this study is the 8-weeks patency rate after placement of double bare as well as technical and clinical success rates.
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
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Malignant gastric outlet obstruction
- •Symptoms compatible with gastric outlet obstruction
- •An inoperable condition because of extent of disease or patient's conditions
排除标准
- •History of enteral stent placement, undergone gastric surgery.
- •Additional small bowel stenosis distal to gastric outlet obstruction.
- •Refuse to be enrolled to study.
结局指标
主要结局
The patency rate at 8 weeks after placement.
时间窗: 8 weeks
次要结局
- re-stenosis rate(8 weeks)
- migration rate(8 weeks)
- Technical and clinical success rates(up to 8 weeks)
研究者
Chan Gyoo Kim
Senior scientist
National Cancer Center, Korea
