Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- elastography strain ratio
研究概览
简要总结
The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.
详细描述
Evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan. Eligible patients should have either enlarged discrete N2/N3 lymph nodes, or central tumor or enlarged N1 lymph nodes with normal mediastinal lymph nodes. Exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes.
Outcomes: Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. Receiver operating characteristic (ROC) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. Area under the ROC curve will be calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •enlarged discrete N2/N3 lymph nodes
- •central tumor with normal mediastinal lymph nodes
- •enlarged N1 lymph nodes with normal mediastinal lymph nodes
排除标准
- •metastatic disease
- •severe co-morbidity that disqualified surgical treatment
- •mediastinal infiltration by tumor
- •small peripheral lung tumor with normal-sized mediastinal lymph nodes
结局指标
主要结局
elastography strain ratio
时间窗: up to 7 months
Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV)
次要结局
未报告次要终点
研究者
Aleš Rozman
MD, specialist from pulmonary diseases
The University Clinic of Pulmonary and Allergic Diseases Golnik
