19 Versus 22-Gauge Fine Needle Biopsy (FNB) Needles for Endoscopic Ultrasound Guided Liver Biopsy (EUS-LB): A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Number of Specimens for Which a Histologic Diagnosis Could be Made Based Upon the Amount of Tissue Obtained With the Needle
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-gauge needle, therefore in this study the investigators hope to compare the tissue yields of a 22-gauge fine needle biopsy (FNB) needle, in comparison to conventional 19-gauge. The investigators predict that 19 and 22 gauge FNB needle will demonstrate similar diagnostic accuracy, with less visible blood artifact. Similarly the investigators predict the safety to be equal.
详细描述
3 BACKGROUND AND SIGNIFICANCE Chronic liver disease has a number of causes, and leads to significant mortality and morbidity in the United States. It has been estimated that roughly 36,000 individuals die annually from the burden of chronic liver disease, thus early diagnosis and intervention are paramount to preventing such complications. Though serologic markers and non-invasive diagnostic imaging modalities are used as a method for determining the underlying disease process, these methods lack the specificity of determining etiology of a patient's chronic liver disease. Therefore, liver biopsy remains the "gold standard" for obtaining valuable diagnostic and prognostic information.
At present there exist several methods for liver tissue acquisition. The most widely accepted method remains percutaneous route (PLB), which utilizes percussion or imaging to localization the biopsy site. The issue with this approach is its potential complication of post-procedural pain in up to 84%, bleeding in 1/2500-10,000 procedures, with under 1/10,000 of these cases being fatal. Another means for obtaining tissue samples is the transjugular route (TLB), which also allows for portal pressure measurement, and is usually reserved for patients with coagulopathy.
More recently, endoscopic ultrasound guided liver biopsy (EUS-LB) has been developed as a newer LB technique. The feasibility of EUS-LB for liver lesions has been validated yielding excellent diagnostic results in several studies. This technique has also been evaluated for hepatic parenchymal disease with up to 90% diagnostic yield. Subsequently, EUS-LB using a 19-gauge needle was compared to percutaneous/transjugular routes showing at least comparative, and in some instances improved sample acquisition, versus other methods. Different 19-gauge needles have been utilized in this setting yielding variable diagnostic specimens. However, there has yet to be comparison of 19 versus a 22-gauge core biopsy needle for EUS-LB. The safety profile with the 19g needle is remarkably good; it seems logical that a smaller needle would be at least as good, if not better.
Primary End Points
- Proportion of cases for which a histologic diagnosis could be made based upon the amount of tissue obtained with the needle (using total portal structures > 5 or length of the longest piece (LLP) > 15 mm).
- Number of portal tracts (PT) in the specimen
- Aggregate specimen length (ASL), length of the longest piece (LLP), and degree of fragmentation Secondary End Points
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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
Number of Specimens for Which a Histologic Diagnosis Could be Made Based Upon the Amount of Tissue Obtained With the Needle
时间窗: 7 days
Defined by total portal structures \> 5 or length of the longest piece \> 15 mm) Subjects underwent a left liver biopsy using a 19-gauge FNA needle, 22-gauge FNB needle, right liver biopsies also using the 19-gauge FNA and 22-gauge FNB. FNA-fine needle aspiration FNB-fine needle biopsy
次要结局
- The Number of Patients With Pain 1 Day After Needle Biopsy(1 days)
- The Number of Patients With Pain 7 Day After Needle Biopsy(7 days)
- The Number of Patients Requiring Medical Care After Needle Biopsy(7 Days)
- Number of Portal Tracts (PT) in the Specimen (Total) Under Histologic Examination(7 days)
- The Number of Specimens With a Visible Core After Needle Biopsy(Day of Procedure)
- The Number of Specimens With a Visible Clot After Needle Biopsy(Day of Procedure)
- The Number of Patients With Visible Bleeding After Needle Biopsy(7 days)
- Aggregate Specimen Length Under Histologic Examination(7 days)
- Length of the Longest Piece Under Histologic Examination(7 days)