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临床试验/NCT03315767
NCT03315767Unknown不适用

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.

University of Ulm1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2017年1月10日最近更新:
适应症
干预措施

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

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

Other

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

Other

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

发起方
University of Ulm
申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Seufferlein

Head of Department Internal Medicine I

University of Ulm

研究点 (1)

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