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CompletedNCT01644656Updated Sep 6, 2018

Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)

An interventional study of ARFI ultrasound in Portal Hypertension and Chronic Liver Disease, sponsored by VA Connecticut Healthcare System. Completed at 2 sites in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2018-09-06.

Sponsored by VA Connecticut Healthcare System · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.

Read the detailed description

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.
02

Conditions studied

  • Portal Hypertension
  • Chronic Liver Disease

Keywords

  • portal hypertension
  • cirrhosis
  • ARFI
  • diagnostic study
03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 500 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

VA Connecticut Healthcare System is the lead sponsor of 40 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
  • presence of comorbid conditions conferring a life expectancy of less than 1 year
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
500 participants (actual)

Study arms

  • Experimental
    acoustic radiation force impulse (ARFI)

    Imaging of liver and spleen using modified ultrasound

    Device: ARFI ultrasound

Interventions

  • DeviceARFI ultrasound

    ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures

    Also known as: acoustic radiation force impulse

06

What researchers measure

Primary outcomes

  1. correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)

    Both measurements are estimates of portal hypertension (defined as equal to HVPG greater than 10 mmHg).

    Time frame: Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours

07

Study locations

2 sites
  • Yale-New Haven Hospital
    New Haven, Connecticut 06511, United States
  • VA Connecticut Healthcare System
    West Haven, Connecticut 06516, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01644656
Lead sponsor
VA Connecticut Healthcare System
Responsible party
Sponsor
First posted
Jul 19, 2012
Start date
Jul 2012
Primary completion
Sep 2018
Completion
Sep 2018
Last update
Sep 6, 2018

Study contacts

Guadalupe Garcia-Tsao, MD
principal investigator · VA Connecticut Healthcare System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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