Diagnostic Value of Endobronchial Ultrasound(EBUS) With a Guide Sheath(GS) for Peripheral Pulmonary Lesions(PPLs) Without Fluoroscopy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The difference of diagnostic value of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.
详细描述
The investigators evaluated the efficacy and safety of transbronchial biopsy (TBB) and bronchial brushing by endobronchial ultrasonography (EBUS) with a guide sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope center, Shanghai chest Hospital affiliated to Shanghai JiaoTong University School, China. Department of pulmonary medicine, Fukushima Medical University, Japan.Patients are divided into two groups, EBUS-GS-X-ray group and EBUS-GS group.Each subject will be randomized to each group.The study is expected to enroll 100 patients at 2 centers (China:75, Fukushima:25).
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
- •Individuals eligible for inclusion are patients that the CT scan appearance of the PPLs showed the longest diameter was more than 2 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 EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone
时间窗: Up to half year
The diagnostic value mean sensitivity and specificity in two groups
次要结局
- The difference of complications of EBUS-GS-TBLB with fluoroscopy as compared to EBUS-GS-TBLB alone(Up to half year)
研究者
Jiayuan Sun
Director, Endoscope Center, Shanghai Chest Hospital
Shanghai Chest Hospital