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

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.

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.

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.

Liver and spleen-elastography assessed by ARFI-technique and the portal vein flow value-assessment by ultrasound investigation.

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

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.