NCT00859742撤回不适用
Endobronchial Ultrasound Guided Transbronchial Needle Aspiration for the Mediastinal Re-staging After Induction Therapy in Non-small Cell Lung Cancer. A Prospective Study
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.
研究概览
简要总结
The aim of this study is to determine the diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in patients with non-small cell lung cancer.
Primary objective:
- To determine the sensitivity, specificity, positive predictive value, negative predictive value and the accuracy of EBUS-TBNA in the detection of mediastinal metastasis in mediastinal re-staging after induction treatment.
Secondary objectives:
- To compare the diagnostic values of EBUS-TBNA and integrated PET/CT in mediastinal re-staging
- To evaluate the changes of ultrasonographic features of mediastinal lymph nodes after induction therapy
- To determine procedure related complications
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
- •Histologically proven non-small cell lung cancer
- •Patients who have initially histologically proven N2 disease (Stage IIIA)
- •Patients who underwent induction treatment (chemotherapy or chemoradiation therapy) and are considred for surgery
- •Written informed consent
排除标准
- •Contraindications for bronchoscopy
- •Medically inoperable patients
- •Patients who are found to have M1 disease, inoperable T4 disease or supraclavicular metastasis after induction treatment
研究组 & 干预措施
EBUS-TBNA
Experimental
干预措施: EBUS-TBNA, integrated PET/CT (Procedure)
结局指标
主要结局
The diagnostic values of EBUS-TBNA in the mediastinal re-staging after induction treatment in non-small cell lung cancer.
时间窗: 1.5 years
次要结局
- The diagnostic values of integrated PET/CT in the mediastinal re-staging after induction treatment in non-small cell lung cancer(1.5 years)
- The changes of ultrasonographic features of mediastinal lymph nodes after induction therapy(1.5 years)
研究者
Bin Hwangbo
Principal Investigator
National Cancer Center, Korea
研究点 (2)
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