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临床试验/NCT02245295
NCT02245295已完成不适用

Impact of Sedation Technique on the Diagnostic Accuracy of Endobronchial Ultrasound-guided Needle Aspiration (EBUS-TBNA)

University of Zurich1 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2014年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
232
试验地点
1
主要终点
Diagnostic accuracy

研究概览

简要总结

There is a paucity of data concerning the impact of the sedation technique used for endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) on diagnostic accuracy. The aim of this retrospective study is to compare diagnostic accuracy of EBUS-TBNA in deep and moderate sedation, and to investigate other possible determinants of diagnostic accuracy in three lymph node locations (mediastinal, subcarinal, and hilar).

The first consecutive patients at the University Hospital Zurich undergoing EBUS-TBNA for selective sampling in deep sedation are compared with the first consecutive patients in moderate sedation between 2006 and 2014. Diagnoses based on EBUS-TBNA were compared with those on surgical or radiological follow-up.

详细描述

Between September, 2007 and January 31, 2014, all consecutive patients who undergo EBUS-TBNA at the University Hospital Zurich for selective assessment of enlarged (≥ 1 cm by CT or ultrasound) or suspected (enhanced fluorodeoxyglucose (FDG) activity in PET/CT) lymph nodes were enrolled. Demographic and clinical data, procedural reports and cytological findings were collected from medical records. Computed tomography (CT) or PET/CT scans were prospectively reviewed to gather the size and standardized uptake value (SUV) of FDG of each sampled lymph node. The cytological findings obtained with EBUS-TBNA were verified by histological examination, if a surgical biopsy (mediastinoscopy, thoracoscopy, or thoracotomy) was carried out following EBUS-TBNA, or alternatively by clinical and radiological follow-up data.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • EBUS-TBNA

排除标准

  • No exclusion criteria

结局指标

主要结局

Diagnostic accuracy

时间窗: 1-6 months

Sensitivity, negative predictive value

次要结局

  • Lymph node morphology(1-6 months)
  • EBUS technique(1-6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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