19-Gauge Fine Needle Aspirate (FNA) Versus 19-Gauge Fine Needle Biopsy (FNB) Needles 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
- 40
- 试验地点
- 2
- 主要终点
- Pre-processing Length of the Longest Piece (LLP)
研究概览
简要总结
Chronic liver disorders (CLD) are a major cause of morbidity and mortality for individuals in the US. Though serologic analysis will often lead to a conclusive diagnosis, liver biopsy remains an important method for helping to determine the etiology and stage of LD. Percutaneous liver biopsy (PLB), transjugular liver biopsy (TLB) and surgical liver biopsy (SLB) are alternative methods for obtaining hepatic tissue. In recent years endoscopic ultrasound guided-liver biopsy (EUS-LB) has come to the forefront as a safe and effective method for obtaining tissue in CLD. There are several studies of the safety of EUS-LB as well as the adequacy of specimens obtained in this fashion. Most studies involve a 19-g needle, therefore in this study we hope to compare the tissue yields of a 19-g fine needle biopsy (FNB) needle, in comparison to conventional 19-g fine needle aspiration (FNA) needle. We predict that 19-g FNA and 19-g FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly, we predict the safety to be equal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Patients undergoing EUS-LB
- •Platelet count > 50,000
- •International normalized ratio (INR) < 1.5
- •Age > 18 years
- •Non-pregnant patients
排除标准
- •Age < 18 years
- •Pregnant patients
- •Inability to obtain consent
- •Anticoagulants or anti-platelet agents use (excluding aspirin) within the last 7-10 days
- •Platelet count < 50,000
- •Presence of ascites
- •Known liver cirrhosis
结局指标
主要结局
Pre-processing Length of the Longest Piece (LLP)
时间窗: up to 5 days
Pre-processing Length of the longest piece (LLP) measured in centimeter
次要结局
- Portal Triads Quantity (Median)(3-5 days)
- Post-processing Length of the Longest Piece (LLP)(3-5 days)
- Number of Participants With LLP Pre-processing Length Less Than 2 cm or Greater Than 2 cm(3-5 days)
- Pre-processing Aggregate Specimen Length (ASL)(3-5 days)
- Post-processing Aggregate Specimen Length (ASL)(3-5 days)
- Portal Triads Number (Mean)(3-5 days)
- Number of Participants With Fewer Than 11 Portal Triads or More Than 11 Portal Triads(3-5 days)
- No. of Fragments > 9 mm, Mean (SD)(3-5 days)
- Specimen Quality for Histologic Diagnosis(3-5 days)
- Length of Longest Piece(Number Analyzed)