Clinical Outcomes of Cryobiopsy for Peripheral Pulmonary Lesions - A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Diagnostic yield based on pathologic diagnosis
研究概览
简要总结
As the former radial endobronchial ultrasound (R-EBUS) guided transbronchial forcep biopsy of peripheral pulmonary nodules has some limitations, the purpose of this study is to investigate a novel biopsy technique, transbronchial cryobiopsy, in patients with peripheral pulmonary nodules.
详细描述
This is a prospective, single arm, open label trial to assess the diagnostic accuracy and safety of the transbronchial cryobiopsy in patients with peripheral pulmonary nodule using a 1.1mm cryoprobe, combined with bronchoscope (with/without guide sheath), R-EBUS, virtual bronchoscopy navigation, and fluoroscopy.
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
- •Patient with peripheral lung nodule less than 30mm on CT scan referred for biopsy
- •Written informed consent after participant's information
排除标准
- •Central lesion (visible on bronchoscope) or presence of metastatic lymph node (not requiring radial EBUS)
- •Pure GGO lesion
- •Patients at increased risk of bleeding
- •Cannot stop agents such as antiplatelet agent or anticoagulant therapy
- •Coagulopathy: Thrombocytopenia (< 100,000/mm3) or prolonged PT (INR > 1.5)
- •Patient with existing or risk of pulmonary and cardiovascular decompensation
- •Intolerance to sedation
- •Vulnerable groups such as pregnant woman, breast feeding, etc.
- •Previously diagnosed cancer patient who needs re-biopsy for genetic susceptibility
结局指标
主要结局
Diagnostic yield based on pathologic diagnosis
时间窗: up to 6 months
Diagnostic yield based on pathologic diagnosis is defined as percentage of definitive pathological diagnosis by transbronchial cryobiopsy. If the bronchoscopic procedure fails to diagnose malignancy, the gold standard will be the results of additional procedures such as repeated bronchoscopic biopsy, percutaneous needle aspiration, surgical biopsy, or CT follow-up without any invasive procedure.
次要结局
- Diagnostic yield based on clinical diagnosis(up to 6 months)
- Adverse events(up to 1 week)