Randomized Trial of Fluoroscopy Use for Radial Endobronchial Ultrasound-guided Biopsy of Peripheral Lung Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Diagnostic yield
研究概览
简要总结
The purpose of this study is to determine whether the use of fluoroscopy improves the diagnostic yield of peripheral pulmonary lesions' biopsy guided by radial endobronchial ultrasound (with the use of a guide sheath).
详细描述
See above
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive patients referred for the bronchoscopic diagnosis of peripheral pulmonary lesions at the Institut Universitaire de Cardiologie et de Pneumologie de Québec(not visible endobronchially)
- •Adults over the age of 18
排除标准
- •Therapeutic anticoagulation
- •Antiplatelet therapy other than aspirin
- •Known hemorrhagic diathesis
- •Acute respiratory failure
- •Pregnancy
- •Inability to provide informed consent
结局指标
主要结局
Diagnostic yield
时间窗: Upon production of pathology results, usually within 2 weeks after the test
Diagnostic yield of radial endobronchial ultrasound-guided biopsy for peripheral lung lesions defined as the proportion of patients in whom a specific diagnosis is established by radial endobronchial ultrasound-guided biopsy. The analysis will be stratified by lesion size, location, the presence of the bronchus sign, type of echographic image obtained (central/peripheral), physician involved, resident involvement.
Sensitivity and specificity
时间窗: Upon completion of ancillary or confirmatory tests, usually within 2 months after the test
Sensitivity and specificity are determined separately for malignancy and benign etiologies. Case records will be reviewed for patients with non-diagnostic specimen and results from other diagnostic procedures (TTNA, surgical biopsy) will be reviewed. For patients without further diagnostic tests, stability or progression of the lesion over time will be used for etiology attribution.
次要结局
- Lesion localization(Immediate (during the test))
- Procedure duration(During the test)
- Complications(Immediately during the test and up to 4 hours after the test)