Clinical trial NCT03315767: Spleen-ARFI-assisted-Portal-Hypertension-Evaluation-Study (SAPHES)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension, Portal
Keywords: HVPG
portal hypertension
ARFI
portal vein flow
advanced liver chronic disease (ACLD)
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in ARFI-elastography value for spleen due to beta-blocker therapy
timeFrame: 6 and 12 weeks
Secondary outcomes:
measure: Correlation between changes in HVPG-values and ARFI-elastography values for liver
timeFrame: 6 and 12 weeks
measure: Correlation between changes in HVPG-values and ARFI-elastography values for spleen
timeFrame: 6 and 12 weeks
measure: Correlation between changes in HVPG-values and portal vein flow measurements
timeFrame: 6 and 12 weeks
measure: Correlation between changes in grade of esophageal varices and HVPG-values
timeFrame: 12 weeks
measure: Correlation between changes in grade of esophageal varices and ARFI-values for liver
timeFrame: 12 weeks
measure: Correlation between changes in grade of esophageal varices and ARFI-values for spleen
timeFrame: 12 weeks
measure: Correlation between changes in grade of esophageal varices and Portal vein flow
timeFrame: 12 weeks
measure: Change in ARFI-elastography value for liver due to beta-blocker therapy
timeFrame: 6 and 12 weeks
measure: Change in portal vein flow value due to beta-blocker therapy
timeFrame: 6 and 12 weeks
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
Study officials:
affiliation: University of Ulm
name: Eugen Zizer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.