Sample Adequacy and Diagnostic Accuracy of a 22 Gauge FNB Needle vs a 19G FNB Needle for EUS-guided Liver Biopsy: a Prospective Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 2
- 主要终点
- Sample adequacy
研究概览
简要总结
EUS-guided liver biopsy (EUS-LB) is increasingly used to diagnose patients with liver disease, especially in anxious patients who need sedation. There is an ongoing debate about the optimal needle size for EUS-LB. Some clinicians prefer a thinner 22-gauge biopsy needle because they presume it to be safer, and some studies show that their performance is the same as a thicker 19-gauge needle. However, some other studies show that the adequacy and diagnostic accuracy of a 19-gauge needle is better, and the rates of adverse events are the same. In this study, we aimed to compare the adequacy and diagnostic accuracy of samples obtained by the same endoscopist from the same liver lobe during the same session.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients with unexplained elevation of liver enzymes and suspected hepatic paranchymal disease
排除标准
- •Patients who had malignancy
- •Patients who have decompensated cirrhosis
- •Presence of ascites
- •Patients with coagulopathy (platelets < 50.000 μ/ mL and INR > 1.5)
- •The use of anticoagulant agents
- •Pregnancy
- •Unable to provide written informed consent
结局指标
主要结局
Sample adequacy
时间窗: 1 month
The sample must have at least 11 complete portal tracts and the length of the longest specimen should be at least 15mm
次要结局
- Adverse events(1 week)
研究者
Salih Tokmak
Assoc.Prof. of GI
Duzce University