NCT03232684已完成不适用
Rapid On-site Evaluation of EBUS-TBNA Samples From Intrathoracic Lymphadenopathy; Can it be Reliably Performed by a Pulmonologist?
Maggiore Bellaria Hospital, Bologna1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年6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
- 200
- 试验地点
- 1
- 主要终点
- Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samples
研究概览
简要总结
The study is aimed at verifying if a pulmonologist in training can reliably assess the adequacy of EBUS-TBNA samples from intrathoracic lymphadenopathy after a period of training provided by an experienced pathologist.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication to sampling of intrathoracic lymphadenopathy based on computed tomography (CT) and/or positron emission tomography (PET)/CT findings
- •Signed informed consent
排除标准
- •High risk conditions for the performance of bronchoscopy and endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA)
- •High risk condition for deep sedation (ASA 4)
- •Pregnancy
结局指标
主要结局
Accuracy with which the pulmonologist will identify inadequate EBUS-TBNA samples
时间窗: Up to 1 week
The Outcome 1 will be measured by verifying the agreement between the pulmonologist judgment and the pathologist judgment, the latter being the gold standard
次要结局
- Accuracy with which the pulmonologist will be able, in case of adequate EBUS-TBNA sample, to assign the specimen to one of the following specific diagnoses: 1) reactive lymph node; 2) malignancy; 3) granulomatous inflammation(Up to 1 week)
研究者
Rocco Trisolini
Director, Interventional Pulmonology Unit
IRCCS Azienda Ospedaliero-Universitaria di Bologna
研究点 (1)
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