The Effectiveness and Safety of Percutaneous Lung Biopsy Guided by Electromagnetic Navigation Real-time Positioning Technology
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion.
研究概览
简要总结
The goal of this clinical trial is to evaluate the diagnostic efficacy and safety of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology in peripheral lung lesions. The main question it aims to answer are: the effectiveness and safety of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.
Participants will undergo CT-guided percutaneous lung biopsy or percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years old
- •Imaging examination showed peripheral lung lesions
- •Selected patients need to complete routine preoperative examinations such as blood routine examination, coagulation function, electrocardiogram, chest CT, etc
- •There is no contraindication for puncture biopsy
- •Good compliance, able to cooperate with research and observation
- •Fully informed of the purpose and method of the study, agreed to participate in the study, and signed the informed consent form
排除标准
- •Severe cardiopulmonary insufficiency, extreme weakness and intolerance of patients
- •The patient is allergic to lidocaine and midazolam
- •The site to be biopsied has a high risk of bleeding such as bronchial artery penetration or suspected lung metastasis of renal cancer
- •Unstable angina pectoris, congestive heart failure, severe bronchial asthma
- •The patient did not agree to participate in the study
- •Participation in other studies within three months without withdrawal or termination will affect the observation of this study
- •The researcher believes that there is any person who is not suitable for the selection
结局指标
主要结局
Diagnostic accuracy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology for diagnosis of pleural effusion.
时间窗: 7 days after the lung biopsy
The diagnosis would be confirmed according to the pathological results or multidisciplinary discussion results (if interstitial lung disease is suspected, the multidisciplinary discussion results shall be recorded). The diagnostic efficacy of percutaneous lung biopsy guided by electromagnetic navigation real-time positioning technology will be compared with that of CT-guided percutaneous lung biopsy for diagnosis of pleural effusion.
次要结局
- Operation time(during the operation of lung biopsy)
研究者
Gang Hou
Principal Investigator
China-Japan Friendship Hospital