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

Hypertension, Portal Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03315767
• Other study ID #: SAPHES
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2017
• Last updated: October 16, 2017
• Start date: January 10, 2017
• Est. completion date: December 2018

Study information

• Verified date: October 2017
• Source: University of Ulm
• Contact: Eugen Zizer, MD
• Phone: 0049-73150044751
• Email: eugen.zizer[@]uniklinik-ulm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: December 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Portal

Intervention

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.
• HVPG-measurement
Evaluation of Portal Hypertension by HVPG-measurement

Locations

Country	Name	City	State
Germany	Universitätsklinikum Ulm	Ulm

Sponsors (1)

Lead Sponsor	Collaborator
University of Ulm

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in ARFI-elastography value for spleen due to beta-blocker therapy	ARFI-elastography: measured in m/s	6 and 12 weeks
Secondary	Correlation between changes in HVPG-values and ARFI-elastography values for liver	HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s	6 and 12 weeks
Secondary	Correlation between changes in HVPG-values and ARFI-elastography values for spleen	HVPG-values: measured in mmHg; ARFI-elastography: measured in m/s	6 and 12 weeks
Secondary	Correlation between changes in HVPG-values and portal vein flow measurements	HVPG-values: measured in mmHg; Portal vein flow: measured in cm/s	6 and 12 weeks
Secondary	Correlation between changes in grade of esophageal varices and HVPG-values	esophageal varices: modified Poquet classification; HVPG-values: measured in mmHg	12 weeks
Secondary	Correlation between changes in grade of esophageal varices and ARFI-values for liver	esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s	12 weeks
Secondary	Correlation between changes in grade of esophageal varices and ARFI-values for spleen	esophageal varices: modified Poquet classification; ARFI-elastography: measured in m/s	12 weeks
Secondary	Correlation between changes in grade of esophageal varices and Portal vein flow	Portal vein flow: measured in cm/s; esophageal varices: modified Poquet classification	12 weeks
Secondary	Change in ARFI-elastography value for liver due to beta-blocker therapy	ARFI-elastography: measured in m/s	6 and 12 weeks
Secondary	Change in portal vein flow value due to beta-blocker therapy	Portal vein flow: measured in cm/s	6 and 12 weeks