Conventional vs Ultrathin Bronchoscopy With Transbronchial Needle Aspiration for the Diagnosis of Peripheral Pulmonary Lesions: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 142
- 主要终点
- Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm
研究概览
简要总结
This study's purpose is to evaluate whether the use of an ultra-thin bronchoscope can improve sensitivity and diagnostic yield in peripheral pulmonary nodules. The ultra-thin probe is expected to reach further bronchi and allow to reach peripheral lesions. Moreover, the ability to identify molecular pattern of lung cancer is essential nowadays, and it will be therefore evaluated.
详细描述
142 patients with at least one peripheral pulmonary nodule will be enrolled. They will underwent randomization in 2 arms: patients in the first arm will undergo transbronchial needle aspiration with a conventional bronchoscope patients in the second arm will undergo transbronchial needle aspiration with a ultra-thin bronchoscope. Every bronchoscopy will be performed by the same operator and will contemplate 3 passes for each nodule, followed by Rapid On-Site Evaluation (ROSE) assessed by a dedicated cytologist. If the cytological on-site evaluation is negative in patients in the first arm, they will be shifted to the second arm. Histological and molecular diagnosis will be assessed by a dedicated pathologist. Data will be collected and analyzed.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18years;
- •presence of at least one peripheral pulmonary lesion ≤ 3 cm on CT scan;
- •ability to give an informed consent.
排除标准
- •coagulopathy or bleeding diathesis that cannot be corrected;
- •severe refractory hypoxemia;
- •unstable hemodynamic status;
- •inability to give an informed consent.
结局指标
主要结局
Assess if sensitivity is higher in the "ultrathin" arm than in the "conventional" arm
时间窗: through study completion, an average of 6 months
percentage
次要结局
- Assess if diagnostic yield is higher in the "ultrathin" arm than in the "conventional" arm(through study completion, an average of 6 months)
研究者
Stefano Gasparini
Professor
Università Politecnica delle Marche