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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ARFI-elastography and portal vein flow measurement | Diagnostic Test | Liver and spleen-elastography assessed by ARFI-technique and the portal vein flow value-assessment by ultrasound investigation. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eugen Zizer, MD | Contact | 0049-73150044751 | eugen.zizer@uniklinik-ulm.de | |
| Mark Hänle | Contact | 0049-7315000 | mark.haenle@uniklinik-ulm.de |
| Name | Affiliation | Role |
|---|---|---|
| Eugen Zizer, MD | University of Ulm | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Ulm | Recruiting | Ulm | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36117519 | Derived | Binzberger A, Hanle M, Pfahler M, Kratzer W, Seufferlein T, Zizer E. Spleen and Liver Stiffness Evaluation by ARFI Imaging: A Reliable Tool for a Short-Term Monitoring of Portal Hypertension? Int J Hepatol. 2022 Sep 9;2022:7384144. doi: 10.1155/2022/7384144. eCollection 2022. |
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| ID | Term |
|---|---|
| D006975 | Hypertension, Portal |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| HVPG-measurement | Diagnostic Test | Evaluation of Portal Hypertension by HVPG-measurement |
|
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 |