Endobronchial Ultrasound Transbronchial Needle Aspiration (EBUS-TBNA) Versus Flexible 19G Endobronchial Ultrasound Transbronchial Needle (Flex 19G EBUS-TBNA) in the Assessment of Mediastinal and Hilar Lymph-adenopathy: a Randomised Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
研究概览
简要总结
This is a prospective randomised diagnostic clinical study to determine whether the use of a new flexible sampling needle can improve the yield of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical reasons as deemed necessary by the managing physician or multidisciplinary team will be randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be performed under local anaesthesia using conscious sedation or general anaesthesia according to usual practice at the trial centre. Specimens will be placed in saline and formalin and forwarded to the pathology laboratory. The specimens will be spun down to create a cell pellet which will undergo cytological and histological examination as per usual protocol at the trial centre.The pathologist, who will be blinded as to which technique was used to obtain the sample, will grade the quality, quantity, and cellularity of the specimens.
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, Outcomes Assessor)
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
- •written informed consent
排除标准
- •Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
- •Inability to obtain informed consent
结局指标
主要结局
The difference in quality of diagnostic tissue obtained between the two study arms following 4 separate needle punctures per lymph node
时间窗: 1 week
Both specimens (cell pellet and tissue fragments) will be assessed by means of a semiquantitative assessment of material (normal lymph node or lesional tissue) present using the formal scoring system described by Mair
次要结局
- The difference between the two study arms in the percentage of lymph nodes sampled where enough tissue is obtained for complete immunohistochemical and genetic mutation analysis(1 week)
- The difference in complication rates between the two study arms(1 month)
- The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with sarcoidosis(1 week)
- The difference between the two study arms in yield (quantity of diagnostic material) in patients ultimately diagnosed with lymphoma(1 week)
- The difference in sensitivity for detecting sarcoidosis between the two study arms(1 week)
- The difference in sensitivity for detecting lymphoma between the two study arms(1 week)
研究者
Felix JF Herth
Prof. Dr. med.
Heidelberg University