NCT01779388已完成不适用
Role of Bronchoscopy Assisted by Electromagnetic Navigation (EMN) in the Diagnosis of Small Pulmonary Nodules of Indeterminate Nature. A Prospective Study by the European Lung Cancer Working Party.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Capability of diagnosing lung nodule with ENB (Sensitivity)
研究概览
简要总结
Due to CT screening, a lot of peripheral nodule not accessible to conventional endoscopy will be found. Electromagnetic navigation directed bronchoscopy (ENB) is a new technique needing validation. the primary aim of the study is to compare ENB to radiologically guided bronchoscopy, considered the standard comparator.
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
- •Presence on a conventional or low dose chest CT at least one lung nodule 5-20 mm in its largest axis, of indeterminate nature; the nodule must be positive at PET-CT examination (in case of PET-CT negative, only follow-up is proposed)
- •The pulmonary nodule(s) must be known for less than 6 months
- •The nodule appearance can be solid, presents as a ground glass opacity with solid component or as pure ground glass opacity
- •Availability for participating in the detailed follow-up of the protocol
- •Signed informed consent.
- •Age > 18 years
排除标准
- •Nodules found in the context of an active infection or for whom, the clinical context and/or additional available investigations (serology, microbiological samplings, immune abnormalities) show that cancer diagnosis is unlikely
- •Nodules found in the context of an active previously documented disease that can be associated with pulmonary nodules (anthracosilicosis, histoplasmosis, tuberculosis, autoimmune or rheumatoid diseases ...)
- •Calcified nodule
- •Anticoagulation therapy of any type that cannot be suspended for the duration of the investigation
- •Respiratory failure, recent myocardial infarction (less than 3 months prior to the date of lung nodule screening), uncontrolled angina pectoris, congestive cardiac failure, cardiac arrhythmia, uncontrolled infectious disease or any other physical, biological or psychological factor which may prevent adherence to the study protocol or which may impair the patient's tolerance to the endoscopy and/or the general anaesthesia
- •Presence of a implanted cardiac device (pace-maker, defibrillator, ...)
- •Pregnant women
结局指标
主要结局
Capability of diagnosing lung nodule with ENB (Sensitivity)
时间窗: After the procedure
Calculate the sensitivity of each endoscopic technique in obtaining the diagnostic of the pulmonary nodule
次要结局
- Prediction of malignancy(After the procedure)
研究者
研究点 (2)
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