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临床试验/NCT02398864
NCT02398864Unknown不适用

Accuracy and Safety of Endobronchial Ultrasound (EBUS) in Suspected Non-malignant Mediastinal Lymphadenopathy

Hannover Medical School0 个研究点目标入组 120 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
Sensitivity of EBUS-diagnosis

研究概览

简要总结

To examine whether EBUS with transbronchial needle aspiration (TBNA) can accurately and safely diagnose enlarged lymph nodes in the chest in patients without suspected malignancy

详细描述

There is no single method to investigate mediastinal LN invasion. Hence, a patient may have to undergo several tests and procedures. Noninvasive and invasive approaches are employed. Within the invasive techniques, endoscopic ultrasonography with needle aspiration (EUS-FNA) and endobronchial ultrasonography with transbronchial needle aspiration (EBUS-TBNA) are gaining importance in mediastinal staging. Endobronchial Ultrasound (EBUS) is a procedure that is performed via flexible bronchoscopy under moderate sedation for visualization of lymph nodes in the chest and biopsy under real-time guidance usually for the staging of lung cancer or evaluation of enlarged lymph nodes. In addition, lung lesions or masses can be visualized and biopsied in the same sitting. The use of EBUS has enhanced the safety and diagnostic yield of flexible bronchoscopy. It provides ultrasonographic images and permits needle aspiration under direct vision for cytology specimen analysis. As more evidence is being accumulated on these staging approaches, the number of cervical mediastinoscopies, considered as the gold-standard for mediastinal staging, is diminishing.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • adults (18 Years and older) with mediastinal lymphadenopathy.

排除标准

  • known or suspected malignancy
  • no informed consent
  • pts with anterior mediastinal lesions
  • contraindications to EBUS

结局指标

主要结局

Sensitivity of EBUS-diagnosis

时间窗: 2 years

Sensitivity defined as the proportion of participants with a positive EBUS-diagnosis accordant to final diagnosis, specificity, positive predictive value, negative predictive value and accuracy will be determined

次要结局

  • Risk factors related with the procedure(2 years)
  • Risk factors related with the development of complications(2 years)

研究者

申办方类型
Other
责任方
Sponsor

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