Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy: Yield and Predictors of a Positive Aspirate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions
研究概览
简要总结
The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.
详细描述
In a recent systematic literature review (Rivera PM, Mehta AC; Chest 2007; 132: 1318-1488) TBNA showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). However, the Authors conclude that the data regarding TBNA in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). We designed the present study to assess the performance characteristics of TBNA, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and older
- •Pulmonary nodule (< 3 cm) or mass (> 3 cm) at computed tomography
排除标准
- •Refusal to sign informed consent
- •Uncontrolled coagulopathy
- •Pregnancy
结局指标
主要结局
Assess sensitivity, specificity and accuracy of TBNA in the diagnosis of peripheral pulmonary lesions
时间窗: 1 year
次要结局
- Evaluate the predictor variables associated with a positive TBNA result(1 year)
- Compare the performance characteristics of TBNA and transbronchial lung biopsy(1 year)