跳至主要内容
临床试验/NCT02156505
NCT02156505Unknown4 期

Phase IV Study of Double Bare Self-expandable Metallic Stent for Malignant Gastric Outlet Obstruction

National Cancer Center, Korea2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2013年1月最近更新:
适应症

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

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Chan Gyoo Kim

Senior scientist

National Cancer Center, Korea

研究点 (2)

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