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

NCT ID: NCT03315767

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-10

Study Completion Date

2018-12-31

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.

Conditions

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Hypertension, Portal

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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cirrhosis patients

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.

Group Type OTHER

ARFI-elastography and portal vein flow measurement

Intervention Type DIAGNOSTIC_TEST

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

HVPG-measurement

Intervention Type DIAGNOSTIC_TEST

Evaluation of Portal Hypertension by HVPG-measurement

Interventions

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ARFI-elastography and portal vein flow measurement

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

Intervention Type DIAGNOSTIC_TEST

HVPG-measurement

Evaluation of Portal Hypertension by HVPG-measurement

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Ulm

OTHER

Sponsor Role lead

Responsible Party

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Thomas Seufferlein

Head of Department Internal Medicine I

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eugen Zizer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Ulm

Locations

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Universitätsklinikum Ulm

Ulm, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Eugen Zizer, MD

Role: CONTACT

Phone: 0049-73150044751

Email: [email protected]

Mark Hänle

Role: CONTACT

Phone: 0049-7315000

Email: [email protected]

Facility Contacts

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Eugen Zizer, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36117519 (View on PubMed)

Other Identifiers

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SAPHES

Identifier Type: -

Identifier Source: org_study_id