Evaluation of Thin and Ultrathin Bronchoscopy With Transbronchial Needle Aspiration and Radial Probe Endobronchial Ultrasound for Peripheral Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules
研究概览
简要总结
To collect data on diagnostic yield of thin and ultrathin bronchoscopes with radial probe endobronchial ultrasound (radial EBUS) and transbronchial needle aspiration (TBNA) during routine standard of care bronchoscopy for peripheral pulmonary lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 age 18 and older
- •Patients presenting with peripheral pulmonary lesions 1-7cm in greatest diameter on axial CT or PET scan in need of bronchoscopic biopsy for clinical purposes
排除标准
- •Patients who are unable to undergo flexible bronchoscopy as determined by the bronchoscopist prior to the procedure
- •Patients unwilling or unable to provide informed consent.
结局指标
主要结局
Overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules
时间窗: Receipt of cytology/histopathology results (approximately 7 days)
-To determine overall diagnostic yield (concentric and eccentric lesions) for peripheral pulmonary nodules utilizing using a standard of care combined approach of 4mm thin and 3mm ultrathin bronchoscopes with TBNA and radial EBUS and compare it to a historical baseline diagnostic yield of 60% established at Washington University School of Medicine (WUSM) when using TBNA and radial EBUS and a 4mm thin bronchoscope.
次要结局
- Types of deficiencies associated with medical device(From start of procedure through end of procedure (day 1))
- Ability to successfully convert ultrasound images from eccentric to concentric view by exchanging the 4mm thin bronchoscope for the 3mm ultrathin bronchoscope(From start of procedure through end of procedure (day 1))
- Diagnostic yield of bronchoscopy utilizing a 3mm bronchoscope for eccentric lesions(Receipt of cytology/histopathology results (approximately 7 days))
- Incidence of related adverse events(Up to 4 days following procedure)
- Procedure time measured in minutes from oral scope insertion to scope removal upon completion of the bronchoscopy procedure(From start of procedure through end of procedure (day 1))
- Size of target lesions measured at the greatest diameter in centimeters(From start of procedure through end of procedure (day 1))