A Randomized Prospective Trial of Rapid On-Site Evaluation of Transbronchial Needle Aspirate Specimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- MaineHealth
- 主要终点
- diagnostic yield
研究概览
简要总结
Purpose: Previous studies suggested an increased diagnostic yield for bronchoscopic (FB) transbronchial needle aspirate (TBNA) specimens from mediastinal lymph nodes when using rapid on-site evaluation by cytopathology (ROSE) but were limited by lack of randomization. The investigators performed the first randomized-prospective trial comparing ROSE(R) to no on-site cytopathology assessment (NR).
Methods: All patients referred were eligible. 78 patients were randomized to R or NR groups. For R procedures, further specimens were deferred until results were available from the on-site cytopathologist. Diagnoses made by all procedures were recorded. The primary end-points were specimen adequacy and diagnostic yield.
研究设计
- 研究类型
- Interventional
- 主要目的
- Diagnostic
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients included all adults referred for bronchoscopy with anticipated TBNA.
排除标准
- •Patients were to be excluded only if the attending physician felt ROSE must be used for diagnosis or if the patient refused consent.
研究组 & 干预措施
ROSE for TBNA
干预措施: ROSE (Other)
NR
no on-site cytopathology assessment (NR)
结局指标
主要结局
diagnostic yield
次要结局
未报告次要终点