Multicenter, Open-label, Prospective Randomized Controlled Trial of Radial Endobronchial Ultrasonography and Virtual Bronchoscopy Navigation for the Peripheral Pulmonary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- Diagnostic Efficacy of navigational bronchoscopy in each study arm
研究概览
简要总结
Peripheral pulmonary lesions are of growing importance in respiratory field. Early detection of lung cancer, tuberculosis and other diseases often needs a bronchoscopic investigation with different types of navigation. Current randomized clinical study is intended to compare three different modalities of navigation in bronchial tree - virtual bronchoscopy (VBN), radial endobronchial ultrasound (EBUS) and combination of both techniques.
详细描述
Current randomized clinical study is intended to compare three different modalities of navigation in bronchial tree - virtual bronchoscopy, radial EBUS and combination of both techniques. Around 300 patients with incidentally detected peripheral pulmonary lesions will be enrolled in 9 centers among Russia. All patients after obtaining an informed consent will be randomized in 1:1:1 fashion to three study groups depending on type of navigation technique used. All patients will undergone navigational bronchoscopy with rEBUS (group A), VBN (group B) and rEBUS+VBN (group C), data on diagnostic efficacy and safety of each modality of navigation will be 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
- •Patients with newly diagnosed unverified solitary or multiple (up to 3) peripheral pulmonary lesions (PPLs)
- •PPL size 5 - 40 mm
- •Actual chest CT scan (<31 days prior to navigation bronchoscopy), collimation 1 mm, pulmonary window, DICOM format
- •Age > 18 years
- •Signed Informed consent form
- •Willing and ability to undergone a navigational bronchoscopy
排除标准
- •Unability to undergone navigation bronchoscopy for any reason
- •Any malignant disease during last 36 months
- •Known central endobronchial lesion of any cause
- •HIV-infection
结局指标
主要结局
Diagnostic Efficacy of navigational bronchoscopy in each study arm
时间窗: At the end of study enrollment
Incidence of final diagnoses confirmed by navigational bronchoscopy for each study arm
次要结局
- Efficacy of each endoscopic biopsy modality in confirmation of final diagnosis(At the end of study enrollment)
研究者
Ilya Sivokozov
Head of Respiratory Endoscopy Department
Central TB Research Institute