The Study for Diagnostic Value and Safety of Transbronchial Mediastinal Cryobiopsy Combined With EBUS-TBNA in Mediastinal Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 271
- 试验地点
- 2
- 主要终点
- diagnostic yield
研究概览
简要总结
The clinical study is aimed to prospectively evaluate the diagnostic accuracy and the safety of adding transbronchial mediastinal cryobiopsy to standard sampling in mediastinal diseases.
详细描述
A traditional method, endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) was used to be compared. The patients involved were randomly divided into two groups. In the experimental group, EBUS-TBMCB was performed following EBUS-TBNA while in the other group, EBUS-TBNA was performed respectively. The samples obtained in the two groups were analyzed by the pathologists. Patients were followed up for confirming the diagnosis and complications. The diagnostic accuracy and prevalence of procedure-related adverse events were compared between the 2 groups.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=15 years;
- •More than one mediastinal lesions with diameter >= 1cm was detected by thoracic CT;
- •Indication of biopsy to identify the etiology, including recently discovered mediastinal lesions or combination of clinical respiratory symptoms and complicated lung lesions implicated by thoracic image ;
- •Completion of necessary preoperative laboratory examination and other examinations such as cardiac ultrasound or CTA when necessary, in order to exclude potential contradictions;
- •Informed consent form achievement.
排除标准
- •Contradictions to bronchoscopy examination such as severe cardiopulmonary diseases, coagulation disorders, intolerance to anesthesia or endoscopic operation and so on;
- •Failure to detect the mediastinal lesions in ultrasonic landscape;
- •Cysts or abscess;
- •Requirements for additional procedures other than EBUS examination (such as endobronchial biopsy);
- •Psychiatric disorders or severe neurosis.
- •Participation in other clinical experiments in recent 3 months;
- •Any other conditions considered to be inappropriate to be involved in this study.
结局指标
主要结局
diagnostic yield
时间窗: through study completion, an average of 1 year
percentage of patients for whom the EBUS procedures provided a definite diagnosis in each arm
prevalence of the procedure-related adverse events
时间窗: through study completion, an average of 1 year
the ratio of the number of patients who had adverse events caused by the procedure and the number of all the patients who have undergone this procedure in each arm
次要结局
- sample size(through study completion, an average of 1 year)
- consumed time(through study completion, an average of 1 year)
- sample adequacy(through study completion, an average of 1 year)
研究者
Ye Fan
Principal Investigator
Third Military Medical University