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Spleen-ARFI-assisted-Portal-Hypertension-Evaluation-Study (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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03315767
Acronym
SAPHES
Enrollment
45
Registered
2017-10-20
Start date
2017-01-10
Completion date
2018-12-31
Last updated
2017-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Portal

Keywords

HVPG, portal hypertension, ARFI, portal vein flow, advanced liver chronic disease (ACLD)

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.

Interventions

DIAGNOSTIC_TESTARFI-elastography and portal vein flow measurement

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

DIAGNOSTIC_TESTHVPG-measurement

Evaluation of Portal Hypertension by HVPG-measurement

Sponsors

University of Ulm
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in ARFI-elastography value for spleen due to beta-blocker therapy6 and 12 weeksARFI-elastography: measured in m/s

Secondary

MeasureTime frameDescription
Correlation between changes in HVPG-values and ARFI-elastography values for liver6 and 12 weeksHVPG-values: measured in mmHg; ARFI-elastography: measured in m/s
Correlation between changes in HVPG-values and ARFI-elastography values for spleen6 and 12 weeksHVPG-values: measured in mmHg; ARFI-elastography: measured in m/s
Correlation between changes in HVPG-values and portal vein flow measurements6 and 12 weeksHVPG-values: measured in mmHg; Portal vein flow: measured in cm/s
Correlation between changes in grade of esophageal varices and ARFI-values for liver12 weeksesophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s
Correlation between changes in grade of esophageal varices and HVPG-values12 weeksesophageal varices: modified Poquet classification; HVPG-values: measured in mmHg
Correlation between changes in grade of esophageal varices and Portal vein flow12 weeksPortal vein flow: measured in cm/s; esophageal varices: modified Poquet classification
Change in ARFI-elastography value for liver due to beta-blocker therapy6 and 12 weeksARFI-elastography: measured in m/s
Change in portal vein flow value due to beta-blocker therapy6 and 12 weeksPortal vein flow: measured in cm/s
Correlation between changes in grade of esophageal varices and ARFI-values for spleen12 weeksesophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s

Countries

Germany

Contacts

Primary ContactEugen Zizer, MD
eugen.zizer@uniklinik-ulm.de0049-73150044751
Backup ContactMark Hänle
mark.haenle@uniklinik-ulm.de0049-7315000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026