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

Sponsor

University of Ulm (Other)

Overall Status

Unknown status

CT.gov ID

NCT03315767

Collaborator

(none)

Enrollment

Location

Arm

22.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension, Portal	Diagnostic Test: ARFI-elastography and portal vein flow measurement Diagnostic Test: HVPG-measurement	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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.

Actual Study Start Date :

Jan 10, 2017

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in ARFI-elastography value for spleen due to beta-blocker therapy [6 and 12 weeks]
ARFI-elastography: measured in m/s

Secondary Outcome Measures

Correlation between changes in HVPG-values and ARFI-elastography values for liver [6 and 12 weeks]
HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s
Correlation between changes in HVPG-values and ARFI-elastography values for spleen [6 and 12 weeks]
HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s
Correlation between changes in HVPG-values and portal vein flow measurements [6 and 12 weeks]
HVPG-values: measured in mmHg; Portal vein flow: measured in cm/s
Correlation between changes in grade of esophageal varices and HVPG-values [12 weeks]
esophageal varices: modified Poquet classification; HVPG-values: measured in mmHg
Correlation between changes in grade of esophageal varices and ARFI-values for liver [12 weeks]
esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s
Correlation between changes in grade of esophageal varices and ARFI-values for spleen [12 weeks]
esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s
Correlation between changes in grade of esophageal varices and Portal vein flow [12 weeks]
Portal vein flow: measured in cm/s; esophageal varices: modified Poquet classification
Change in ARFI-elastography value for liver due to beta-blocker therapy [6 and 12 weeks]
ARFI-elastography: measured in m/s
Change in portal vein flow value due to beta-blocker therapy [6 and 12 weeks]
Portal vein flow: measured in cm/s

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Ulm	Ulm		Germany

Sponsors and Collaborators

University of Ulm

Investigators

Principal Investigator: Eugen Zizer, MD, University of Ulm

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thomas Seufferlein, Head of Department Internal Medicine I, University of Ulm

ClinicalTrials.gov Identifier:

NCT03315767

Other Study ID Numbers:

SAPHES

First Posted:

Oct 20, 2017

Last Update Posted:

Oct 20, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Thomas Seufferlein, Head of Department Internal Medicine I, University of Ulm

advanced liver chronic disease (ACLD)

Additional relevant MeSH terms:

Hypertension, Portal

Hypertension

Study Results

No Results Posted as of Oct 20, 2017