NCT02920944已完成不适用
Technical Feasibility and Diagnostic Yield of New 20-gauge Procore Needle for EUS-guided FNA Biopsy in Solid Pancreatic Lesions; Comparison With 22-gauge Procore Needle
Seung Bae Yoon2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2016年7月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- single diagnostic yield of the histologic core
研究概览
简要总结
This study aims to examine technical feasibility and diagnostic yield of new 20-gauge Procore needle for EUS-guided fine needle biopsy in solid lesions by comparing with 22-gauge Procore needle. The study design is prospective, randomized study.
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients older than 20 years referred to our medical center for EUS-FNB with diagnosed or suspected solid pancreatic masses according to clinical evaluation and imaging studies.
排除标准
- •cystic pancreatic lesions, patients haemodynamically unstable or with severe coagulopathy (international normalized ratio [INR] > 1.5 or platelet count < 50,000 cells/cubic millimeter [cmm3]), patients unable to suspend anticoagulant/anti-platelet therapy, pregnancy, inability or refusal to give informed consent, and refusal to participate in the study.
研究组 & 干预措施
EUS-FNB with 20-gauge
Experimental
EUS-FNB with 20-gauge procore needle
干预措施: EUS-FNB with 20 gauge ProCore needle (Device)
EUS-FNB with 22-gauge
Active Comparator
EUS-FNB with 22-gauge procore needle
干预措施: EUS-FNB with 22 gauge ProCore needle (Device)
结局指标
主要结局
single diagnostic yield of the histologic core
时间窗: up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy
次要结局
- total diagnostic yield of the histologic core(up to 5 minutes after endoscopic ultrasound-guided fine needle biopsy)
研究者
Seung Bae Yoon
Professor
Seoul St. Mary's Hospital
研究点 (2)
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