NCT03802266Unknown不适用
Electromagnetic Navigation Guided Versus CT-guided Transthoracic Needle Aspiration (TTNA) in the Diagnosis of Early Peripheral Lung Cancer, a Randomized Open Label Trial
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- Diagnostic rate
研究概览
简要总结
The purpose of this study is to compare Electromagnetic navigation guided with CT-guided transthoracic needle aspiration (TTNA) in the diagnosis of pulmonary peripheral nodule.
Primary endpoints：Diagnostic rate Secondary endpoints：operating time、adverse events Study design: Multicenter、randomized、open lebel
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patients with 0.8-3 cm, high-risk pulmonary peripheral nodules that need biopsy for pathological diagnosis;
- •Patients who are older than 18 year-old;
- •Patients voluntarily join the study and give written informed consent for the study.
排除标准
- •Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
- •Large blood vessels or important structures on the puncture path of peripheral lung tumors；
- •Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
研究组 & 干预措施
CT group
Active Comparator
CT-guided Transthoracic Needle Aspiration
干预措施: CT-guided Transthoracic Needle Aspiration (Device)
Electromagnetic Navigation group
Experimental
Electromagnetic Navigation Guided Transthoracic Needle Aspiration
干预措施: Electromagnetic Navigation guided transthoracic needle aspiration (Device)
结局指标
主要结局
Diagnostic rate
时间窗: 18 months
次要结局
- Operating time(18 months)
- Adverse events(18 months)
研究者
Hua Zhong
Professor Hua Zhong
Shanghai Chest Hospital
研究点 (1)
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