NCT07478913已完成不适用
Predictive Value of Endobronchial Sonographic Patterns in Diagnosis of Mediastinal Lymphadenopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1- evaluate the morphological characteristics of mediastinal LNs in real time 2- assess the nature of LNs before puncturing either benign or malignant using EBUS and corelate them with the histopathological outcome.
研究概览
简要总结
This study aims to assess the value of endosonographic patterns of EBUS bronchoscopy in diagnosis of patients with mediastinal lymphadenopathy and correlate it with the histopathological diagnosis.
详细描述
All patients will undergo EBUS-bronchoscopy using 22-gauge needle of EBUS.
- Lymph node stations and numbers were determined according to the International Association for the Study of Lung Cancer classification.
- Systemic evaluation of Lymph nodes according to ERS guidelines starting with any potential N3 lymph nodes followed by N2 lymph nodes, and N1 lymph nodes Ultrasound features of suspected lymph nodes were categorized according to: B-mode, Color Power Doppler Index (CPDI) After evaluation of ultrasound features, a TBNA using a 22- G needle were performed. Three samples were taken from each node or lesion for +/- rapid on-site evaluation ROSE (using Haematoxylin and Eosin stain) and histopathological examination.
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
- •Age ≥ 18 years.
- •patients who underwent chest enhanced CT before EBUS-TBNA examination to assess the nature of mediastinal and hilar enlarged lymph nodes.
排除标准
- •Contraindication to needle biopsy (e.g. use of anticoagulation drugs, bleeding diathesis).
- •Patients unfit for bronchoscopy and general anaesthesia by international guidelines.
- •Lymph Nodes that are not accessible or technically difficult by EBUS-TBNA e.g. Station 5,6.
结局指标
主要结局
1- evaluate the morphological characteristics of mediastinal LNs in real time 2- assess the nature of LNs before puncturing either benign or malignant using EBUS and corelate them with the histopathological outcome.
时间窗: 2 years
1. EBUS sonographic features can guide the selection of LNs for biopsy 2. EBUS sonographic features can guide internal puncture site within the LN and biopsy efficiency as a complementary diagnostic value.
次要结局
未报告次要终点
研究者
研究点 (1)
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