Endobronchial Ultrasound "Elastography" and "Tissue Harmonic Imaging" for Characterisation of Hilar and Mediastinal Lymph Nodes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"
研究概览
简要总结
Several benign and malignant diseases are associated with hilar and mediastinal lymphadenopathy. Endobronchial elastography that is an imaging procedure used for the visualization of tissue elasticity and "Tissue Harmonic Imaging (THI)" might be useful for the differentiation of benign and malignant lymph nodes.
详细描述
Patient enrolment and data acquisition is to be carried out on a prospective basis. Patients with hilar and/or mediastinal lymphadenopathy and indication for EBUS-TBNA are enroled. It is planned to evaluate 100 lymph nodes by elastography and THI. All patients will undergo diagnostic bronchoscopy at one study centre in Heidelberg.
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
- 否
入选标准
- •Indication for EBUS-TBNA
- •Patient has provided written informed consent
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of elastography and "Tissue Harmonic Imaging"
时间窗: Once after bronchoscopic procedure
Correlation of imaging results and cytological results after bronchoscopic procedure
次要结局
- Safety of endobronchial use of elastography and "Tissue Harmonic Imaging" assessed by Incidence of adverse events(during diagnostic bronchoscopy procedure)
研究者
Felix JF Herth
Prof. Dr. med.
Heidelberg University