跳至主要内容
临床试验/NCT05075655
NCT05075655Unknown不适用

Diagnosis of Lymphoma Using Endobronchial Ultrasound Guided Miniforceps Biopsy.

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年4月20日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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