19Gauge Fine Needle Biopsy (FNB) Versus 22Gauge FNB for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Randomized Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Length of Longest Piece
研究概览
简要总结
To determine the adequacy of EUS-LB using a 19G core needle compared to a 22G core needle in a prospective randomized study.
详细描述
The 19Gauge core and 22Gauge core needles have both been used for EUS-LB with good success. Previous studies have reported good safety and tissue adequacy with both the needles, but the head-on comparison between these two needles is lacking.
This is a prospective randomized trial comparing the biopsy specimen adequacy of 19Gauge versus 22Gauge core needles for EUS-LB.
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
- None
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing EUS-LB
- •Platelet Count > 50,000
- •International normalized ratio (INR) < 1.5
- •Age > 18 years of age
- •Non-Pregnant Patients
排除标准
- •Age < 18 Years of Age
- •Pregnant Patients
- •Inability to obtain consent
- •Anticoagulants or anti-platelet agents (excluding aspirin) within the last 7 -10 days
- •Platelet count < 50,000
- •Presence of Ascites
- •Known Liver Cirrhosis
研究组 & 干预措施
19Gauge Fine Needle Biopsy
19Gauge Fine Needle
干预措施: 22G FNB (Procedure)
19Gauge Fine Needle Biopsy
19Gauge Fine Needle
干预措施: 19G FNB (Procedure)
22 Gauge Fine Needle Biopsy
22Gauge Fine Needle
干预措施: 19G FNB (Procedure)
22 Gauge Fine Needle Biopsy
22Gauge Fine Needle
干预措施: 22G FNB (Procedure)
结局指标
主要结局
Length of Longest Piece
时间窗: Up to 5 Days
Length of the longest piece of the liver tissue obtained
次要结局
- Adverse Events and Serious Adverse Events(7 to 10 Days Post Procedure)
- Aggregate Specimen Length(3 to 5 Days)
- Degree of Fragmentation(3 to 5 Days)
- Number of Portal Tracts in the Specimen(3 to 5 Days)
研究者
David L. Diehl
Principal Investigator
Geisinger Clinic