Prospective Evaluation of Non-invasive ARFI-elastography of Liver and Spleen and Portal Flow Measurement in Comparison With Invasive HVPG (Hepatic Venous Pressure Gradient)-Measurement for Patients With Portal Hypertension.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in ARFI-elastography value for spleen due to beta-blocker therapy
研究概览
简要总结
This study evaluates correlation in changes of HVPG-pressure values and stiffness values (ARFI) for spleen and liver and flow-volume values in Portal vein in patients with liver cirrhosis/Portal Hypertension, respectively, after new-admission of beta-blocker therapy.
详细描述
Portal Hypertension is the most important risk factor for development of liver cirrhosis-linked complications (e.g. ascites, variceal bleeding, hepatocellular carcinoma, etc.). The invasive HVPG-technique is the standard-of-care Investigation for Evaluation of Portal Hypertension. Administration of Beta-Blocker-therapy results in dropping of the elevated Portal vein pressure values so Overall-survival rate and incidence of liver-cirrhosis-linked complications can be ameliorated. Ultrasound-based Investigation of liver and Spleen-stiffness and of portal-vein-flow-volume, respectively, are the non-invasive methods for Evaluation of Portal Hypertension. But the cut-off values for detection of significant Portal Hypertension by the ultrasound investigation strongly vary depending on the study performed. This study evaluates the changes in ARFI-assisted elastography measurements of liver and spleen and in portal vein flow values, respectively, compared with the recorded Delta in invasive hepatic vein pressure gradient (HVPG)-values for patients with portal hypertension and new administered beta-blocker-therapy. The aim of this study is to evaluate value drop in liver- and Spleen-stiffness and portal-vein-flow required in corelation to a significant drop in HVPG-pressure after new-administered beta-blocker therapy.
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
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
- •liver cirrhosis
- •portal hypertension
- •indication to beta-blocker-therapy
排除标准
- •contraindication to beta-blocker-therapy
- •HVPG-measurement not feasible
- •portal vein thrombosis
- •hematologic underlying disease as the source for enlarged/stiff spleen or liver
研究组 & 干预措施
cirrhosis patients
ARFI-elastography and portal vein flow measurement: Liver and spleen of patients with a scheduled HVPG-investigation will be examined by an ARFI-elastography-investigation. Additionally the portal vein flow will be assessed.
This examination will be done at d0 before the start of beta-blocker-administration and repeated as monitoring for portal hypertension treated by beta-blocker after 6 and 12 weeks, respectively.
HVPG-measurement: HVPG-values will be assessed at d0, after 6 and after 12 Weeks, respectively.
干预措施: ARFI-elastography and portal vein flow measurement (Diagnostic Test)
cirrhosis patients
ARFI-elastography and portal vein flow measurement: Liver and spleen of patients with a scheduled HVPG-investigation will be examined by an ARFI-elastography-investigation. Additionally the portal vein flow will be assessed.
This examination will be done at d0 before the start of beta-blocker-administration and repeated as monitoring for portal hypertension treated by beta-blocker after 6 and 12 weeks, respectively.
HVPG-measurement: HVPG-values will be assessed at d0, after 6 and after 12 Weeks, respectively.
干预措施: HVPG-measurement (Diagnostic Test)
结局指标
主要结局
Change in ARFI-elastography value for spleen due to beta-blocker therapy
时间窗: 6 and 12 weeks
ARFI-elastography: measured in m/s
次要结局
- Correlation between changes in grade of esophageal varices and Portal vein flow(12 weeks)
- Correlation between changes in grade of esophageal varices and ARFI-values for liver(12 weeks)
- Correlation between changes in HVPG-values and ARFI-elastography values for liver(6 and 12 weeks)
- Correlation between changes in HVPG-values and ARFI-elastography values for spleen(6 and 12 weeks)
- Correlation between changes in HVPG-values and portal vein flow measurements(6 and 12 weeks)
- Correlation between changes in grade of esophageal varices and HVPG-values(12 weeks)
- Correlation between changes in grade of esophageal varices and ARFI-values for spleen(12 weeks)
- Change in ARFI-elastography value for liver due to beta-blocker therapy(6 and 12 weeks)
- Change in portal vein flow value due to beta-blocker therapy(6 and 12 weeks)
研究者
Thomas Seufferlein
Head of Department Internal Medicine I
University of Ulm
