NCT02268162Unknown不适用
Prospective Multicenter Randomized Control Study on Diagnosis of Individuals With Pulmonary Nodules by Different Bronchoscopy Combination
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 3,228 人开始时间: 2015年4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
- 3,228
- 试验地点
- 1
- 主要终点
- Diagnostic yield for pulmonary peripheral lesions
研究概览
简要总结
This study evaluates the value of different bronchoscopy combination for diagnosing peripheral pulmonary lesions suspected to be cancer. One-third of participants will receive routine bronchoscopy, while one-third of participants will receive bronchoscopy combined with a guiding equipment and the other one-third of participants will receive bronchoscopy combined with two or more guiding equipments. These guiding equipments include virtual bronchoscopic navigation(VBN), endobronchial ultrasonography with a guide sheath(EBUS-GS) and fluoroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible subjects are adults with solitary peripheral pulmonary lesions (mean diameter, ≤30mm and >8mm from axial CT images) suspected to be cancer but were not pathologically confirmed.
排除标准
- •Patient has dysrhythmia or cardiovascular disease that poses a risk during exercise.
- •Patient has uncontrollable hypertension (SBP > 180mmHg).
- •Patient has severe organ dysfunction (shock, severe hepatic and renal dysfunction, massive hemorrhage of upper gastrointestine, diffuse intravascular coagulation(DIC) and massive hemoptysis,etc).
- •Patient has blood coagulation disorders (PT>2 times the upper limit of normal(ULN) or Platelet(PLT)<50000/ul）.
- •Patient has severe dyspnea.
- •Patient is allergic to local anesthetic.
- •Patient is unable to provide informed consent.
- •Patient is not an appropriate candidate for of is unable to tolerate flexible bronchoscopy procedures.
- •Patient has any disease or condition that interferes with completion of initial or follow-up assessments of the effectiveness endpoints.
- •Patient has demonstrated unwillingness or inability to complete screening or baseline data collection procedures.
- •Patient participated in a study of an investigational drug or device within the past 30 days prior to participation in this study, or is currently participating in another clinical study.
- •Female patient of childbearing potential has a positive result from a pregnancy test.
结局指标
主要结局
Diagnostic yield for pulmonary peripheral lesions
时间窗: 7 days
The diagnostic yield for individuals with pulmonary peripheral lesions examined by bronchoscopy with or without guiding equipments
次要结局
- length of operation time using bronchoscopy or bronchoscopy combination(30 minutes)
- length of stay in hospital(7 days)
- hospitalization costs(7 days)
- Number of participants with adverse events or serious adverse events(2 weeks)
研究者
研究点 (1)
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