NCT04687410Unknown不适用
Randomized Comparison of Tissue Quality and Molecular Yield Between a Novel Crown-cut Biopsy Needle (FNB) and a Standard Aspiration Needle (FNA) for EUS Guided Diagnosis of Solid Pancreatic Lesions
Peter Vilmann MD, DSc, HC, FASGE1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年6月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Total tissue area
研究概览
简要总结
The aim of this study is to compare tissue quality and molecular yield between a novel crown-cut biopsy needle (FNB) and a standard aspiration needle (FNA) for EUS-guided diagnosis of solid pancreatic lesions.
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
- •Adult patients with a newly discovered SPL scheduled for EUS-guided tissue acquisition who can understand and provide a written consent.
排除标准
- •Patients with uncorrected coagulopathies (INR >1.5 or platelet count <50,000) or patients treated with anticoagulants that cannot be discontinued.
- •Pregnant or lactating females.
- •Interposed, large vessels between the transducer and the target lesion.
研究组 & 干预措施
FNA
Active Comparator
干预措施: ProControl, MediGlobe (Device)
FNB
Experimental
干预措施: TopGain, Medi-Globe (Device)
结局指标
主要结局
Total tissue area
时间窗: 1 month
Comparison of total total tissue area in um2
Amount of tissue micro-fragments
时间窗: 1 month
Comparison of median number of tissue micro-fragments
Diagnostic tissue area
时间窗: 1 month
Comparison of total diagnostic tissue area in um2
次要结局
- Mean DNA concentration(6 months)
- Suitability for molecular analyses(6 months)
- Diagnostic yield(1 month)
- Diagnostic performance(12 month)
- Adverse event rate(1 month)
研究者
Peter Vilmann MD, DSc, HC, FASGE
Professor
Herlev Hospital
研究点 (1)
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