NCT02196974已完成不适用
Bronchoscopic Approach to the Peripheral Lung Nodule - Endobronchial Ultrasound, Electromagnetic Navigation and Cryobiopsy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- incremental diagnostic yield of cryobiopsy over the standard specimens
研究概览
简要总结
In patients with peripheral lung nodules, what is the additional diagnostic yield of biopsies obtained with flexible cryoprobes compared to standard techniques? For patients with peripheral nodules, we hypothesize use of the cryoprobe will allow larger samples of tissue to be obtained and therefore, will increase the diagnostic yield over conventional techniques
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >18 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
- •Technically difficult nodule location
- •Perceived high risk of pneumothorax or other complications
排除标准
- •Lack of informed consent
- •Nodule less than 1 cm or greater than 6 cm long axis
- •Significant mediastinal adenopathy.
- •No suspected sites of disease outside the thorax amenable to biopsy
- •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.
- •Uncontrolled or irreversible coagulopathy
- •platelets <100
- •INR >1.3
- •Use of clopidogrel in the 7 days prior to bronchoscopy
- •Confirmed or suspected pregnancy
- •Clinically unable to tolerate a pneumothorax or single-lung ventilation
- •Pacemaker or implanted cardiac defibrillator if it is felt that ENB is needed
研究组 & 干预措施
cryobiopsy
Experimental
干预措施: cryobiopsy (Procedure)
结局指标
主要结局
incremental diagnostic yield of cryobiopsy over the standard specimens
时间窗: 1 year after completion of recruitment
次要结局
未报告次要终点
研究者
Paul MacEachern
Clinical Assistant Professor
University of Calgary
研究点 (1)
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