The Comparative Study of Electromagnetic Navigation Bronchoscopic With Ultra-thin Cryobiopsy and Forceps Biopsy in the Diagnosis of Peripheral Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
To investigate the safety and efficacy of ultrafine cryoprobe biopsy by electromagnetic navigation bronchoscopy compared with biopsy forceps in the diagnosis of peripheral pulmonary nodules in a national multicenter randomized controlled trial
详细描述
This project intends to carry out a national multicenter randomized controlled study, with traditional forceps biopsy as the control group and cryobiopsy as the experimental group, to verify the feasibility, effectiveness and safety of electromagnetic navigation bronchoscope-guided cryobiopsy in the diagnosis of peripheral pulmonary nodules, so as to provide an efficient and minimally invasive diagnostic method for the diagnosis of peripheral pulmonary nodules
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 90 years;
- •pulmonary nodules detected by chest CT, suspected malignant nodules or unknown cause should be confirmed by biopsy;
- •chest CT showed that the nodule was located in the segmental bronchus and below, and the maximum diameter of the nodule was 8 mm to 30 mm.It was not accessible by conventional bronchoscopy;
- •if chest CT showed multiple pulmonary nodules, one of the pulmonary nodules was selected as the target lesion.
排除标准
- •contraindications to the bronchoscopy procedure;
- •high risk of bleeding, such as bronchial artery penetration or suspected lung metastasis of renal cell carcinoma;
- •electromagnetic source implanted in the body;
- •contraindications to anesthesia;
- •pregnant woman;
- •participated in other studies within three months and did not withdraw or finish, affect the observation of this study;
- •inability or unwillingness to provide informed consent or comply with the follow-up schedule.
研究组 & 干预措施
Cryobiopsy group
Electromagnetic Navigation Bronchoscopic with Ultra-thin Cryobiopsy
干预措施: Cryobiopsy (Procedure)
Forceps biopsy group
Electromagnetic Navigation Bronchoscopic with Forceps Biopsy
干预措施: Forceps biopsy (Procedure)
结局指标
主要结局
Diagnostic yield
时间窗: follow-up for 12 months
The primary outcome was the diagnostic yield of ENB-guided cryobiopsy and forceps biopsy for diagnosing pulmonary lesions
次要结局
- Adverse events(follow-up for one month)