Randomized Controlled Trial Comparing the Performance of 19 Gauge Versus 22 Gauge EBUS-TBNA Needles in Lung Carcinoma
试验速览
- 阶段
- 3 期
- 发起方
- KU Leuven
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Tissue core
研究概览
简要总结
EBUS-TBNA is often the sole diagnostic test applied in patients with stage IV lung cancer. A limitation of the TBNA needle when using a 22 Gauge needle is the limited ability to procure adequate histological samples. Although a larger 19 Ga needle can procure histological samples as demonstrated by the conventional 19 Ga needle, published data are not existing with respect to molecular diagnostics. A new nitinol-based 19 Ga needle has been developed for EBUS-TBNA. Given the frequent usage of 22 Ga needles for molecular diagnostics and the recent technical advancements in 19 Ga needle technology, we conduct a RCT to compare the performance of both needle types.
详细描述
All patients with (suspected) stage IV lung carcinoma identified on spiral computed tomography scan and requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis, subtyping and genotyping of lung cancer are eligible for participation in this study. Procedural technique : patients undergo an EBUS-TBNA procedure with either the Flex 19 Ga needle or the 22 Ga needle ; all procedures are performed using a linear array echoendosope under moderate sedation (standard practice). Primary endpoint of the study is the presence of core tissue that is defined as a continuous string of material as observed on the microscopic examination. Secondary endpoints are elements relevant to molecular analysis.
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
- •(suspected) stage IV lung carcinoma identified on spiral computed tomography scan
- •requiring an EBUS-TBNA investigation to obtain intrathoracic hilar or mediastinal lymph node tissue for diagnosis
排除标准
- •uncontrolled coagulopathy
- •tracheal stenosis
结局指标
主要结局
Tissue core
时间窗: 14 months
Descriptive tissue characteristics of tumor sample
次要结局
- Tumor cellularity per area of diagnostic tissue(14 months)
- Quantity of DNA extracted(14 months)
- Success rate of Next Generation Sequencing(14 months)
