Non-invasive Evaluation of Portal Hypertension in Patients With Compensated Advanced Chronic Liver Disease by Liver Stiffness Measurement Using Liver Incytes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Platelet Count for Participants With Compensated Advanced Chronic Liver Disease
研究概览
简要总结
This is a cross sectional study that evaluates the relationship between LSM (liver stiffness measurement) by Liver Incytes in patients with cACLD (compensated advanced chronic liver disease) and manifestations of portal hypertension.
详细描述
The purpose of this study is to assess the severity of portal hypertension in people with compensated advanced chronic liver disease (cACLD) who have not undergone liver transplant by measuring liver stiffness with the Liver Incytes device (Velacur) and comparing the performance of LSM (liver stiffness measurement) via Velcaur and transient elastography via FibroScan to esophageal varices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
This is an open label study in that all participants will receive the same study procedures. Participants only receive this Velacur intervention if they are enrolled in this trial.
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
- •Adults aged 18 years or older
- •Ability to provide informed consent
- •Planned standard of care upper endoscopy to screen for varices
- •Planned standard of care transjugular liver biopsy with portal pressure measurement
排除标准
- •Inability or refusal to provide informed consent
- •Fasting for less than three hours prior to the scan
- •Subject is a pregnant or lactating female
- •Subject with current, significant alcohol consumption
- •Patients with a pacemaker or defibrillator
- •Acute hepatitis defined as AST/ALT > 500 U/L
- •post liver transplantation
结局指标
主要结局
Platelet Count for Participants With Compensated Advanced Chronic Liver Disease
时间窗: one day
Comparing the platelet count in the same patient population to determine Velacur's accuracy in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices
Liver Stiffness Measurements for Participants With Compensated Advanced Chronic Liver Disease With and Without Esophageal Varices Upon Esophagogastroduodenoscopy (EGD)
时间窗: one day
Comparing the performance of Velacur by Sonic Incytes to transient elastography via FibroScan® in the same patient population to determine if either test is more accurate in correlating with compensated advanced chronic liver disease (cACLD) for participants with and without esophageal varices.
次要结局
未报告次要终点
研究者
Samer Gawrieh
Professor of Clinical Medicine
Indiana University