Randomized Controlled Trial of Endobronchial Ultrasound Guided Fine Needle Aspiration Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Sensitivity of each needle aspiration technique for diagnosis of malignancy
研究概览
简要总结
Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TBNA) techniques have not been well studied. The investigators will conduct a randomized study comparing the diagnostic yield and specimen quality of EBUS-FNA performed with and without suction applied.
详细描述
Consecutive patients with suspected malignant peribronchial masses or lymph nodes undergoing endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) will be enrolled. All participants will have 4 needle aspirations of each targeted peribronchial lesion. Two needle aspirations will be performed while applying suction and 2 needle aspirations will be performed without applying suction in random order. The investigators will compare the diagnostic yield and the quality of the specimens obtained using the two techniques.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Adult undergoing EBUS at AUBMC for suspected malignancy
排除标准
- •Coagulopathy
- •The lesion cannot be sampled because of intervening tumor or blood vessels.
结局指标
主要结局
Sensitivity of each needle aspiration technique for diagnosis of malignancy
时间窗: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The sensitivity for diagnosing malignancy will be calculated and compared for the two needle aspiration technique.
Diagnostic accuracy of each needle aspiration technique for diagnosis of malignancy
时间窗: Diagnosis of malignancy will be ascertained after 6 month clinical follow up
A pathologist blinded to the needle aspiration technique will review the specimen obtained from each needle aspiration and will assess for presence of malignant cells. The diagnostic accuracy for diagnosing malignancy will be assessed and compared for the two needle aspiration technique.
次要结局
- Negative predicted value of each needle aspiration technique for diagnosis of malignancy(Diagnosis of malignancy will be ascertained after 6 month of clinical follow up)
- Positive predicted value of each needle aspiration technique for diagnosis of malignancy(Diagnosis of Malignancy will be ascertained after 6 month of clinical follow up)
- Adequacy of the needle aspiration sample(Adequacy will be assessed within 1 week from procedure)
- Specificity of each needle aspiration technique for diagnosis of malignancy(Diagnosis of malignancy will be ascertained after 6 month clinical follow up)
研究者
Hassan Chami
Assistant Professor
American University of Beirut Medical Center