Diagnostic Value of Electromagnetic Navigation Bronchoscopy With a Guide Sheath for Peripheral Pulmonary Lesions : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of electromagnetic navigation bronchoscopy with a Guide Sheath(ENB-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) .
详细描述
The investigators evaluated the efficacy and safety of transbronchial lung biopsy (TBLB) and bronchial brushing using electromagnetic navigation bronchoscopy (ENB) with a guide sheath (GS) for the diagnosis of peripheral pulmonary lesions (PPLs) with radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope department, Shanghai chest Hospital affiliated to Shanghai JiaoTong University, China. Department of pulmonary medicine, Shanghai ZhongShan Hospitial affiliated to Shanghai FuDan University, China.Patients are divided into two groups, ENB-GS-TBLB-X-ray group and GS-TBLB-X-ray group.Each subject will be randomized to each group.The study is expected to enroll 60 patients at 2 centers (Shanghai Chest Hospital: 40, Shanghai Zhongshan Hospital: 20).
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
- •clinical and imaging characteristics suggestive of maligancy
- •CT scan appearance of the PPLs showed the longest diameter was more than 1 cm and solid lesions.
排除标准
- •The lesion is close to the pleural membrane
- •Refusal of participation
- •Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
结局指标
主要结局
The Difference of Diagnostic Value of ENB-GS-TBLB as Compared to GS-TBLB
时间窗: Up to half year
The diagnostic yield in the ENB-GS-TBLB and GS-TBLB group was 87.2% and 61% individually.
次要结局
- The Duration Time Difference of ENB-GS-TBLB With Fluoroscopy as Compared to GS-TBLB With Fluoroscopy Alone(Up to half year)
研究者
Jiayuan Sun
Director, Endoscope Center, Shanghai Chest Hospita
Shanghai Chest Hospital