Spleen-ARFI-assisted-Portal-Hypertension-Evaluation-Study (SAPHES)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Hypertension, Portal

Intervention / Treatment
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* Diagnostic Test: ARFI-elastography and portal vein flow measurement
* Diagnostic Test: HVPG-measurement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: liver cirrhosis portal hypertension indication to beta-blocker-therapy Exclusion Criteria: contraindication to beta-blocker-therapy HVPG-measurement not feasible portal vein thrombosis hematologic underlying disease as the source for enlarged/stiff spleen or liver

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: cirrhosis patients<br>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. | Diagnostic Test: ARFI-elastography and portal vein flow measurement<br>* Liver and spleen-elastography assessed by ARFI-technique and the portal vein flow value-assessment by ultrasound investigation.<br>Diagnostic Test: HVPG-measurement<br>* Evaluation of Portal Hypertension by HVPG-measurement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ARFI-elastography value for spleen due to beta-blocker therapy | ARFI-elastography: measured in m/s | 6 and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between changes in HVPG-values and ARFI-elastography values for liver | HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s | 6 and 12 weeks | 
| Correlation between changes in HVPG-values and ARFI-elastography values for spleen | HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s | 6 and 12 weeks | 
| Correlation between changes in HVPG-values and portal vein flow measurements | HVPG-values: measured in mmHg; Portal vein flow: measured in cm/s | 6 and 12 weeks | 
| Correlation between changes in grade of esophageal varices and HVPG-values | esophageal varices: modified Poquet classification; HVPG-values: measured in mmHg | 12 weeks | 
| Correlation between changes in grade of esophageal varices and ARFI-values for liver | esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s | 12 weeks | 
| Correlation between changes in grade of esophageal varices and ARFI-values for spleen | esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s | 12 weeks | 
| Correlation between changes in grade of esophageal varices and Portal vein flow | Portal vein flow: measured in cm/s; esophageal varices: modified Poquet classification | 12 weeks | 
| Change in ARFI-elastography value for liver due to beta-blocker therapy | ARFI-elastography: measured in m/s | 6 and 12 weeks | 
| Change in portal vein flow value due to beta-blocker therapy | Portal vein flow: measured in cm/s | 6 and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HVPG, portal hypertension, ARFI, portal vein flow, advanced liver chronic disease (ACLD)