NCT03890523Unknown不适用
Covered Metallic Segmented Airway Stent Modified With 3D Printing for Gastro-respiratory Fistula Involving Carina and Distal Bronchi
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
- Relief of symptoms
研究概览
简要总结
In this study, the investigators used the covered metallic segmented airway stent modified with 3D printing to treat gastro-respiratory fistula involving carina and distal bronchi 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 gastro-respiratory fistula involving carina and bronchi distal to carina based on the diagnosis by bronchoscopy , gastroscopy and CT.
- •The patients who could not tolerate surgery and did not have clinical improvement after conservative treatment.
排除标准
- •Severe infection
- •coagulation disorders
结局指标
主要结局
Relief of symptoms
时间窗: 1 month
Main symptoms as follows: cough, dysphagia, dyspnea, and expectoration.
Heal of fistula
时间窗: 3 months
The heal of fistula confirmed by gastroscopy, bronchoscopy and CT
次要结局
- Stent patency time(6 months)
- Number of participants with adverse events that are related to stent implantation(6 months)
研究者
Zhongmin Wang
Principal Investigator
Ruijin Hospital
研究点 (2)
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