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

October 16, 2017 updated by: Thomas Seufferlein, University of Ulm

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 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.
Diagnostic test: 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.
Diagnostic test: HVPG-measurement
Evaluation of Portal Hypertension by HVPG-measurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in ARFI-elastography value for spleen due to beta-blocker therapy
Time Frame: 6 and 12 weeks
ARFI-elastography: measured in m/s
6 and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between changes in HVPG-values and ARFI-elastography values for liver
Time Frame: 6 and 12 weeks
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
Time Frame: 6 and 12 weeks
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
Time Frame: 6 and 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 12 weeks
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
Time Frame: 6 and 12 weeks
ARFI-elastography: measured in m/s
6 and 12 weeks
Change in portal vein flow value due to beta-blocker therapy
Time Frame: 6 and 12 weeks
Portal vein flow: measured in cm/s
6 and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Investigators

  • Principal Investigator: Eugen Zizer, MD, University of Ulm

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2017

Primary Completion (ANTICIPATED)

August 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

October 16, 2017

First Submitted That Met QC Criteria

October 16, 2017

First Posted (ACTUAL)

October 20, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 20, 2017

Last Update Submitted That Met QC Criteria

October 16, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAPHES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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