NCT03890575Unknown不适用
Covered Metallic Segmented Airway Stent Modified With 3D Printing for Malignant Stricture Involving Carina and Bronchi Distal to Carina: A Multicenter Study
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Improvement in Dyspnea using Hugh-Jones classication as criteria
研究概览
简要总结
In this study, we used the covered metallic segmented airway stent to treat malignant strictures involving carina and bronchi distal to carina and aimed to determine the feasibility, efficacy and safety of this technique.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with malignant stricture involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy or CT.
排除标准
- •Severe infection
- •Coagulation disorders
结局指标
主要结局
Improvement in Dyspnea using Hugh-Jones classication as criteria
时间窗: 3 days
Hugh-Jones classication: dyspnea scale that includes 5 categories.
Overall survival
时间窗: 6 months
OS is defined as the time from the stent implantation to death due to any cause, or censored at date last known alive.
Stent patency time
时间窗: 2 months
Stent patency time is defined as the time from the stent implantation to stent restenosis or death due to any cause, or censored at date last known alive.
次要结局
- Number of participants with adverse events that are related to stent implantation(2 months)
研究者
Zhongmin Wang
Principal Investigator
Ruijin Hospital
研究点 (2)
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