Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.
试验速览
- 阶段
- 不适用
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- positivity of the procedure in Diagnosis and Subtyping of lymphoma
研究概览
简要总结
The present study aimed to assess the diagnostic performance of ultrasound-guided endobronchial intra-nodal miniforceps biopsy (EBUS-MFB) in the diagnosis of "de novo" mediastinal lymphoma.
详细描述
Every patients will be sampled using both EBUS-MFB and the standard of care EBUS-TBNA (transbronchial needle aspiration).
It is a monocentric investigation. Pathologist will not know the way of sampling while analysing the samples
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
pathologist do not know the technique of sampling used when analysing slides.
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
- •Pathological mediastinal nodes within reach of EBUS sampling on CT-scan.
- •Lymphoma suspicion by a senior clinical hematologist
- •Affiliated to the french public health care insurance
排除标准
- •Peripherical pathological lymph nodes reachable without general anesthesia
- •Antithrombotic medication that cannot be stopped le time of the procedure.
- •Unstable respiratory status
- •History of lymphoma
- •Latex or xylocaine allergia
结局指标
主要结局
positivity of the procedure in Diagnosis and Subtyping of lymphoma
时间窗: up to 3 years
a sample wil be considered positive if it allows the clinical management of the patient, without additional sampling required.
次要结局
- every adverse effect related to the procedure(up to 3 years)
