Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Endobronchial Ultrasound Transbronchial Needle Biopsy (EBUS-TBNB) in the Assessment of Mediastinal and Hilar Lymphadenopathy: a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 6
- 主要终点
- The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
研究概览
简要总结
A prospective diagnostic clinical study randomising patients undergoing endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of enlarged mediastinal and hilar lymph nodes to have sampling using the usual EBUS-TBNA needle or a novel biopsy forceps (EBUS-TBNB).
The study aims to establish whether the use of EBUS-TBNB can significantly increase the diagnostic yield over EBUS-TBNA, without an increase in complication rates.
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
- Double (Participant, Investigator)
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
- •Scheduled for EBUS-TBNA as part of clinical care
- •Lymph nodes larger than 10mm in diameter
- •Age > 18 years
- •Able to provide written informed consent
排除标准
- •Contraindications for needle or forceps biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
- •Inability to obtain informed consent
结局指标
主要结局
The percentage of lymph nodes sampled resulting in a definitive diagnosis (as defined in the protocol) in the two study arms.
时间窗: 18 months
The definition of a "definitive diagnosis" is dependant on the diagnosis and is clarified below: * Carcinoma/lymphoma: The lymph node sample is adequate to make a diagnosis as well as provide immunohistochemistry information enabling subtyping of the tumour. * Sarcoidosis: The presence of well formed epithelioid non-caseating granulomas. * Mycobacterial infection: The presence of caseating granulomas, positive Ziehl Nielson staining for acid fast bacilli, or the tissue successfully cultures Mycobacterium.
次要结局
- The difference in the complication rate between the two study arms(24 months)