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临床试验/JPRN-UMIN000001280
JPRN-UMIN000001280已完成2 期

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

Japan-multinational Trial Organization (JMTO)0 个研究点目标入组 25 人开始时间: 2008年7月31日最近更新:

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

研究者

发起方
Japan-multinational Trial Organization (JMTO)

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