A feasibility study of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in evaluation of mediastinal nodal metastasis of lung cancer - EBUS-TBNA in N2-diagnosis of lung cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
研究概览
简要总结
EBUS-TBNA is a standard procedure for pathological evaluation of mediastinal nodal (N2) status of lung cancer, but its feasibility in potentially operable patients with suspicion of minimal N2 remains unestablished. A prospective multicenter study was conducted to assess the feasibility. Clinical stage-IIIA-N2 non-small cell lung cancer (NSCLC) patients with mediastinal nodal enlargement on CT were eligible; patients were ineligible when CT revealed bulky station N2. When EBUS-TBNA revealed negative results, surgical staging procedures were mandatory. Among 20 eligible patients, EBUS-TBNA provided pathological confirmation of N2 (true-positive) in 12 patients. Among 8 patients with negative results with EBUS-TBNA, 4 patients were pathologically diagnosed of N2 disease with surgical staging procedures (false-negative), and 4 were finally diagnosed of non-N2 disease with nodal dissection by thoracotomy (true-negative). As a result, the sensitivity of EBUS-TBNA for N2 evaluation, the primary endpoint, was 75.0%. There documented no Grade 3-5 adverse event.EBUS-TBNA is safe and useful in pathological evaluation of N2 status even in potentially operable NSCLC patients with suspicion of minimal N2 on preoperative CT.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1, Active infection 2, Any other active malignant tumor
