Combined Application of EBUS-TBNA and EUS-B-FNA in Mediastinal Staging of Lung Cancer; EBUS-TBNA Centered Procedure vs. EUS-B-FNA Centered Procedure, a Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
This study aims to investigate a diagnostic yield and performance characteristics according to the order of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-with bronchoscope-guided transbronchial needle aspiration (EUS-B-FNA) in the mediastinal staging of potentially operable lung cancer. EUS-FNA is a better tolerated procedure than EBUS-TBNA. Therefore, EUS-B-FNA can be the main procedure in a combined approach with EBUS-TBNA and EUS-B-FNA. In group A, the investigators perform EBUS-TBNA first and EUS-B-FNA is performed when necessary. In group B, EUS-B-FNA is first applied and EBUS-TBNA is performed when necessary. The hypothesis is that the diagnostic yield of the EUS centered procedure is as good as that of the EBUS centered procedure and the EUS centered procedure is more tolerable than the EBUS centered procedure. We evaluate diagnostic yields and performance characteristics of each group.
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
- Single (Participant)
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
- •Histologically confirmed or strongly suspected non-small cell lung cancer (NSCLC)
- •Potentially operable patients
排除标准
- •M1 disease
- •Inoperable T4 disease
- •Mediastinal infiltration or extranodal invasion of the mediastinal lymph node visible on chest CT.
- •Confirmed supraclavicular lymph node metastasis
- •Pancoast tumors
- •Medically inoperable patients
- •Contraindications for bronchoscopy and esophageal endoscopy
- •Drug reaction to lidocaine, midazolam,fentanyl
- •Pregnancy
- •Ground glass-dominant nodule ( < 3cm)
结局指标
主要结局
Diagnostic accuracy
时间窗: When the confimative disgnosis is available in all subjects (after surgery) ; 8-12 months
次要结局
- Procedure time(During and just after the procedure ; 5-60 minutes)
- Cardiovascular measurement (change of blood pressure, changes of heart rate, number of patients with arrhythmia)(During the procedure; 0-60 minutes)
- Degree of desaturation(During the procedure; 0-60minutes)
- Discomfort by the procedure(After the procedure ; 2-3hr)
- Number of participants with adverse Events (infection, bleeding requiring intervention, pneumothorax, or any complications requiring hospital admission)(During and after the procedure; 0-2 weeks)
- Lymph node features(During and after the procedure; 0-2hrs)
- Fentanyl/midazolam/lidocaine consumption(After the procedure ; 1-2 hrs)