Completed

Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease

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What is being tested

ARFI ultrasound

Device
Who is being recruted

Digestive System Diseases+4

+ Disease

+ Fibrosis

From 18 to 85 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: July 2012
See protocol details

Summary

Principal SponsorVA Connecticut Healthcare System
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 2012

Actual date on which the first participant was enrolled.

DESIGN The study is designed as a prospective, cross-sectional, diagnostic study in which the investigators will evaluate the use of ARFI to diagnose clinically significant portal hypertension (CSPH defined as hepatic veous pressure gradient (HVPG)greater than 10 mmHg), taking HVPG measurements as gold standard. METHODOLOGY * The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale. * Study population will be recruited among patients from the VA/Yale Liver Clinics or outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.

Official TitleNon-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease
NCT01644656
Principal SponsorVA Connecticut Healthcare System
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

500 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Digestive System DiseasesDiseaseFibrosisHypertension, PortalLiver DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Criteria

3 inclusion criteria required to participate
age 18-85 years
compensated chronic liver disease with suspected or confirmed liver cirrhosis sent for transjugular liver biopsy as part of their routine care
signed informed consent
5 exclusion criteria prevent from participating
known contraindications to the performance of an HVPG measurement or a trans-jugular biopsy
portal thrombosis
previous surgical or transjugular portosystemic shunt
previous total or partial splenectomy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Imaging of liver and spleen using modified ultrasound

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Yale-New Haven Hospital

New Haven, United StatesOpen Yale-New Haven Hospital in Google Maps
Suspended

VA Connecticut Healthcare System

West Haven, United States
Completed2 Study Centers