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, FASGE2 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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Amount of tissue micro-fragments
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.
结局指标
主要结局
Amount of tissue micro-fragments
时间窗: 1 month
Comparison of median number of tissue micro-fragments
Total tissue area
时间窗: 1 month
Comparison of total total tissue area in um2
Diagnostic tissue area
时间窗: 1 month
Comparison of total diagnostic tissue area in um2
次要结局
- Suitability for molecular analyses(6 months)
- Diagnostic yield(1 month)
- Diagnostic performance(12 month)
- Mean DNA concentration(6 months)
- Adverse event rate(1 month)
研究者
Peter Vilmann MD, DSc, HC, FASGE
Professor
Herlev Hospital
研究点 (2)
Loading locations...
相似试验
尚未招募
2 期
Ipas MVA plus versus Wallach Endocell in women with abnormal uterine bleedingAbnormal uterine bleedingendometrial biopsymanual vacumm aspirationtissue adequacyTCTR20140108001avamindradhiraj University428
已完成
不适用
Comparison of Graft Quality and Patient Morbidity Following Palatal Harvesting.Wound PalateGingival RecessionNCT03584906University of Milan60
Unknown
不适用
Fine Needle Biopsy of Solid Pancreatic Mass LesionsPancreatic NeoplasmsNCT04085055AdventHealth130
已完成
不适用
Comparison of between techniques for EUS-guided tissue acquisitioNeoplasmsKCT0004678Hallym University Medical Center-Dongtan155
招募中
不适用
In vivo evaluation of molecular tissue properties of enthesial structures using multispectral optoacoustic tomography (MSOT) and arthrosonography in patients with inflammatory joint diseases (psoriasis, psoriatic arthritis) (MAPSA).L40M07.3PsoriasisOther psoriatic arthropathiesDRKS00024360niversitätsklinikum Erlangen90