Electromagnetic Navigation Bronchoscopy in the Diagnosis of Peripheral Pulmonary Nodules
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group
研究概览
简要总结
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups.
详细描述
The study is designed as a multi-center prospective trial with two arms, ENB-EBUS-GS group and EBUS-GS group, and aimed to evaluate the diagnostic yield and operation time between the two groups. Patients with peripheral pulmonary nodules that need to be confirmed by pathology will be enrolled in the study. A total of 400 patients are expected to be enrolled. EBUS will be used in both group. Biopsy, brushing and washing will be performed when EBUS image present. Brushing, washing and lavage will be performed when EBUS image absent.
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 who are older than 18 year-old.
- •Chest CT shows peripheral pulmonary nodule (8mm<longest diameter≤30mm) suspected to be malignant that need to be confirmed by pathology. The nodule is surrounded by lung parenchyma and invisible in standard bronchoscopy.
- •Patients who agree to undergo bronchoscopy without any contraindications.
- •Patients who have good compliance and sign informed consent.
排除标准
- •Chest CT scan shows that the pulmonary nodule is pure ground glass opacity.
- •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
The difference of diagnostic yield between ENB-EBUS-GS group and EBUS-GS group
时间窗: one year
Diagnostic yield is defined as proportion of true positive and true negative.
次要结局
- The difference of operation time between ENB-EBUS-GS group and EBUS-GS group(one week)
- The difference of complications between ENB-EBUS-GS group and EBUS-GS group(three months)
研究者
Jiayuan Sun
Director, Department of Endoscopy
Shanghai Chest Hospital