NCT06250387Unknown不适用
Prospective Feasibility Study of Endobronchial Ultrasound Transbronchial Cryobiopsy (EBUS-TBCB 1.1 mm Probe) Among Patients With Mediastinal Lymphadenopathies
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- To evaluate the feasibility of EBUS TBCB 1.1 mm probe.
研究概览
简要总结
Mediastinal lymph nodes enlargement with short axis diameter >15 mm is conventionally defined as a mediastinal lymphadenopathy. The causes of mediastinal lymphadenopathy can be malignant or benign, (infectious, inflammatory, and other such as drug toxicity).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patient ≥ 18 years of age
- •Mediastinal and/or hilar lymphadenopathies > 20 mm on an injected chest CT scan
- •Suspicion of lymphoproliferative disease, sarcoidosis or tuberculosis
- •Hypermetabolism of mediastinal and/or hilar lymphadenopathies on PET scan (SUV max > 3)
- •No contraindication for general anesthesia
- •French-speaking Patient
- •-Signed informed consent
排除标准
- •Patient not covered by the French social security system
- •Patient with legal protection
- •Pregnant or breastfeeding patient (if applicable)
- •Patient under guardianship or curatorship
- •Patient deprived of liberty
研究组 & 干预措施
Patients with mediastinal lymphadenopathy
Experimental
Patients with suspicion of lymphoma, sarcoidosis and tuberculosis, presenting with mediastinal lymphadenopathy confirmed by a CT scan and/ or PET scan and patients with previous negative EBUS-TBNA.
干预措施: Endobronchial ultrasound transbronchial cryobiopsy (Procedure)
结局指标
主要结局
To evaluate the feasibility of EBUS TBCB 1.1 mm probe.
时间窗: 6 Months
Number of successes of the procedure. A success is defined by the ability to perform a biopsy.
次要结局
- To estimate the sensitivity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.(7 Months)
- To estimate the specificity of EBUS TBCB probe 1.1 mm in the diagnosis of mediastinal lymphadenopathy.(7 Months)
- To assess the post-procedure complications rate.(1 Month)
- To estimate the procedure time.(Day 0)
研究者
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