Electromagnetic Navigation Bronchoscopy for the Diagnosis of Peripheral Pulmonary Nodules: a Real World Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 479
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
The study is designed as a multi-center prospective trial of ENB for the diagnosis of peripheral pulmonary nodules in the real world. The purpose of the study is to identify the optimal method of using ENB.
详细描述
The study will be conducted at no less than 5 clinical centers. Patients with peripheral pulmonary nodules suspicious for malignancy will be enrolled in the study. ENB will be performed with/without other guided bronchoscopy techniques and/or ROSE. Different biopsy methods will be recorded as well. The primary endpoint is the diagnostic yield of ENB. The secondary endpoints include factors affecting diagnostic yield, operation time, complications, safety and so on.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 who are older than 18 year-old.
- •Chest CT shows peripheral pulmonary nodule (8mm<longest diameter≤30mm) suspicious for malignant that needs to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible with standard bronchoscopy.
- •Patients who agree to undergo bronchoscopy without any contraindications.
- •Patients who have good compliance and sign informed consent.
排除标准
- •Presence of concomitant endobronchial lesion during the brochoscopy procerdure.
- •Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy.
结局指标
主要结局
Diagnostic yield
时间窗: One year
Diagnostic yield is defined as proportion of true positive and true negative. The primary endpoint is diagnostic yield of ENB with/without other guided bronchoscopy techniques or ROSE.
次要结局
- The difference of diagnostic yield among groups of different methods of using ENB(One year)
- Incidence of complications(One year)
- Factors affecting diagnostic yield(One year)
- The difference of diagnostic yield among groups using different locatable guides(One year)
- Operation time(One year)
研究者
Jiayuan Sun
Director, Department of Endoscopy
Shanghai Chest Hospital