A Prospective Trial of Endobronchial Ultrasound- Transbronchial Needle Aspiration Compared to Mediastinoscopy for Mediastinal Lymph Node Staging of Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- The primary outcome measure of the study is to compare the sensitivity of EBUS-TBNA vs. mediastinoscopy.
研究概览
简要总结
Accurate staging of the mediastinum is essential to evaluate prognosis in non-small cell lung cancer and to devise an appropriate treatment plan. Mediastinal staging by surgical techniques (mainly cervical mediastinoscopy) is considered to be the gold standard, although surgical staging is invasive, requires general anesthesia, and is subject to potential serious complications. Endobronchial ultrasound (EBUS)-transbronchial needle aspiration (TBNA) is a new modality for the evaluation of mediastinal and hilar lymph node metastasis from lung cancer. Compared to other diagnostic methods, EBUS-TBNA is a real-time procedure that enables multiple biopsies with high-quality histologic cores under local anesthesia. However, there have been few data on the head-to-head comparisons of mediastinoscopy and EBUS-TBNA. The aim of this prospective study is to determine the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of EBUS-TBNA and mediastinoscopy in identifying N2 and N3 lymph node for patients with non-small cell lung cancer.
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
- •Histology-proven non-small cell lung cancer
- •N2 or N3 lymph node invasion is suspected based on chest CT or PET/CT scans (at least one of three criteria) : 1) enlarged (1cm or more in short axis diameter) mediastinal lymph node(s), 2) FDG uptake in the mediastinal lymph node(s), or 3) FDG uptake in N1 node(s)
- •The patient is otherwise considered a candidate for a surgical treatment with the intention to cure
排除标准
- •Distant metastasis
- •Inoperable T4 disease
- •Confirmed supraclavicular lymph node metastasis
- •Former therapy (chemotherapy or radiotherapy or surgery) for lung cancer
- •Contraindications for bronchoscopy
- •Uncorrected coagulopathy
- •Concurrent other malignancies
- •Suspicious mediastinal lymph node metastasis which are not accessible by EBUS-TBNA or mediastinoscopy (i.e. paraaortic, aortopulmonary window, or paraesophageal lymph nodes)
结局指标
主要结局
The primary outcome measure of the study is to compare the sensitivity of EBUS-TBNA vs. mediastinoscopy.
时间窗: 1 month interval
次要结局
- The secondary outcome measures of the study are to compare the specificity, negative predictive value, positive predictive value, and accuracy of EBUS-TBNA vs. mediastinoscopy.(1 month interval)
研究者
Sang-Won Um
Assistant Professor
Samsung Medical Center