NCT02299830Unknown不适用
Prospective, Open, Multicenter Study of Interventional Pulmonologic Treatment of Malignant Central Airway Stricture
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 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 malignant central airway stricture.
The four techniques are：
- cryotherapy
- argon plasma coagulation
- stent
- snare
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •malignant neoplasm caused central airway stenosis
- •the degree of stenosis is above 50%
- •estimated survival duration is longer than 3 months
- •received 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 malignant neoplasm caused central airway 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
结局指标
主要结局
percentage of the cases that got Ⅰand Ⅱlevel remission
时间窗: the next day after the treatment
次要结局
- Karnofsky Physical scales(the next day after the treatment)
- the values of dyspnea index(the next day after the treatment)
研究者
研究点 (1)
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