Feasibility and Safety of Thin Convex Probe EBUS Scope BF-UC290F for the Diagnosis of Peripheral Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Diagnostic yield of BF-UC290F for PPLs
研究概览
简要总结
The purpose of the study is to evaluate the diagnostic value and safety of Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs)
详细描述
This study will determine the feasibility of the novel thin convex probe endobronchial ultrasound (TCP-EBUS) Scope for the diagnosis of peripheral pulmonary lesions. The primary end point is to clarify the feasibility of using the thin convex probe EBUS scope to biopsy peripheral pulmonary lesions. The secondary objective is to evaluate operation time, sample adequacy, factors affecting the diagnosis rate, etc. The safety, insertion ability, and operability of the thin convex probe EBUS would also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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 older than 18 years old.
- •Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by pulmonary parenchyma and located below the segmental bronchus as seen radiographically.) suspicious of malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinical purposes, and the investigators consider it possible to be biopsied with BF-UC290F (the bronchus adjacent or leading to the PPLs are close to 5mm in diameter, thus BF-UC290F is able to arrival/access).
- •Patients without contraindications of bronchoscopy.
- •Patients have good medical adherence and signed informed consent.
排除标准
- •Peripheral pulmonary lesion is pure ground-glass opacity.
- •Visible lumen lesions during bronchoscopy
- •The lesions were adjacent to the central airway (trachea, left and right main bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS Scope BF-UC290F were conducted without leaf bronchus entry
- •The investigators believe that patient has other conditions that are not suitable for the study.
结局指标
主要结局
Diagnostic yield of BF-UC290F for PPLs
时间窗: Up to 6 months
Diagnostic yield is defined as the proportion of peripheral pulmonary lesions (PPLs) diagnosed via endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in all lesions undergoing bronchoscopy biopsy via EBUS-TBNA.
次要结局
- EBUS scope operation time(Immediately after each operation)
- The total time of lesion access(Immediately after Each Operation)
- Factors affecting the diagnosis rate(Up to 6 months)
- The bronchus level of lesions, and the bronchus level reached with the EBUS scope(During the procedure)
- Specimen adequacy(Up to 6 months)
研究者
Jiayuan Sun
Director, Department of Endoscopy
Shanghai Chest Hospital