NCT00915330已完成不适用
Transbronchial Needle Aspiration With and Without Rapid On-site Cytopathologic Evaluation in the Diagnostic Approach to Hilar/Mediastinal Adenopathy: A Randomized Controlled Trial.
Maggiore Bellaria Hospital, Bologna2 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2009年5月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm
研究概览
简要总结
The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old and older
- •Hilar and/or mediastinal lymphadenopathy (> 1 cm on the short axis, as assessed by contrast-enhanced CT scan (computed tomography))
排除标准
- •Uncontrolled coagulopathy
- •Refusal to sign informed consent
结局指标
主要结局
Examine the diagnostic yield of the TBNA with ROSE arm versus the diagnostic yield of TBNA alone arm
时间窗: 6-12 months
次要结局
- Examine the percentage of inadequate samples in the TBNA with ROSE arm versus the TBNA alone arm(6-12 months)
- Examine the number of biopsy sites in the TBNA with ROSE arm versus the TBNA alone arm(6-12 months)
- Examine the complication rate of bronchoscopy in the TBNA with ROSE arm versus the TBNA alone arm(6-12 months)
研究者
研究点 (2)
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