Prospective, Randomized, Open, Controlled, Multicenter Stucy of Interventional Pulmonologic Treatment of Benign Central Airway Fibrotic Stricture
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- percentage of the cases that got Ⅰand Ⅱlevel remission
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of four interventional pulmonology techniques for the treatment of fibrotic central airway stricture.
The four techniques are：
- balloon dilation
- balloon dilation plus cryotherapy
- balloon dilation plus spiculiform electrosurgery
- balloon dilation plus mitomycin C injection
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •tracheal incision,intubation or bronchial tuberculosis caused central airway fibrotic stenosis
- •the degree of stenosis is above 50%
- •estimated survival duration is longer than 3 months
- •recieved no treatment one month before
- •can understand the statement informed consent
- •agree to enroll in the study
排除标准
- •older than 70 years or younger than 18 years
- •not fibrotic stenosis
- •not central airway stenosis
- •existence of lumina collapse or twisting
- •severe arrhythmia, myocardial ischemia or hypertensive crisis
- •coagulation disorders
- •existence of severe organ disfunction
- •allergic to anesthesia drugs
- •refuse to participate the study
研究组 & 干预措施
balloon dilation
give the cases balloon dilation as the intervention
干预措施: balloon dilation (Device)
balloon dilation plus cryotherapy
give the cases balloon dilation plus cryotherapy as the intervention
干预措施: balloon dilation (Device)
balloon dilation plus cryotherapy
give the cases balloon dilation plus cryotherapy as the intervention
干预措施: cryotherapy (Procedure)
BD plus spiculiform electrosurgery
give the cases balloon dilation plus spiculiform electrosurgery as the intervention
干预措施: balloon dilation (Device)
BD plus spiculiform electrosurgery
give the cases balloon dilation plus spiculiform electrosurgery as the intervention
干预措施: spiculiform electrosurgery (Procedure)
BD plus mitomycin C
give the cases Balloon dilation plus mitomycin C as the intervention
干预措施: balloon dilation (Device)
BD plus mitomycin C
give the cases Balloon dilation plus mitomycin C as the intervention
干预措施: mitomycin C (Drug)
结局指标
主要结局
percentage of the cases that got Ⅰand Ⅱlevel remission
时间窗: 3 months
次要结局
- the values of dispnea index(3 months)
- Karnofsky Physical scales(3 months)