Bronchoscopic Approach to the Peripheral Lung Nodule - An Alternative Approach Using Peripheral Endobronchial Ultrasonography and Electromagnetic Navigation Bronchoscopy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- diagnostic yield
研究概览
简要总结
Patients presenting with solitary or multiple lung nodules often require tissue confirmation in order to guide further management and determine if the lesion is benign or malignant. Several bronchoscopic techniques have emerged which have significantly improved the diagnostic yield of bronchoscopy in this setting, and in particular the combination of peripheral Endobronchial Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy (ENB) has resulted in diagnostic yields of nearly 90%. In an attempt to reduce the significant cost of this combined approach, the sequential use of pEBUS followed by the more costly ENB technique only if a lesion is not identified on the ultrasound image could be as accurate. This study aims to determine the diagnostic yield of this sequential approach in patients with lung nodule(s).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >16 years
- •Lung nodule (s) identified on CT scan
- •Clinical decision to obtain tissue biopsy of lung lesion
- •CT guided biopsy not preferred technique (previous negative CT guided biopsy or technically difficult nodule location or perceived high risk of pneumothorax or other complications)
- •Pleural based lesion only if: Inaccessible by CT guided biopsy or previous CT guided biopsy non-diagnostic
排除标准
- •Lack of informed consent
- •Nodule less than 1 cm or greater than 6 cm long axis
- •Mediastinal adenopathy >2cm short axis on CT chest
- •Evidence of endobronchial abnormality on chest CT
- •Medical contraindication to bronchoscopy
- •Patients with lesions highly suspicious for lung cancer, potentially resectable with lobar or lesser resection and without significantly increased operative risk factors will not be entered into this study prior to surgical evaluation.
- •Patient with implanted electronic medical device
- •Uncontrolled or irreversible coagulopathy (platelets <100, INR >1.3, use of clopidogrel in the 7 days prior to bronchoscopy)
- •Confirmed or suspected pregnancy
结局指标
主要结局
diagnostic yield
次要结局
- sensitivity, specificity, positive and negative predictive value
- Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield
- Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared
- Complication rate