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

This study is currently recruiting participants.
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Verified March 2017 by VA Connecticut Healthcare System
Information provided by (Responsible Party):
VA Connecticut Healthcare System Identifier:
First received: June 19, 2012
Last updated: March 27, 2017
Last verified: March 2017
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.

Condition Intervention
Portal Hypertension Chronic Liver Disease Device: ARFI ultrasound

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Non-invasive Diagnosis of Portal Hypertension by Acoustic Radiation Force Impulse (ARFI) Imaging of the Liver and Spleen in Patients With Chronic Liver Disease

Resource links provided by NLM:

Further study details as provided by VA Connecticut Healthcare System:

Primary Outcome Measures:
  • correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG) [ Time Frame: Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours ]
    Both measurements are estimates of portal hypertension (defined as equal to HVPG greater than 10 mmHg).

Estimated Enrollment: 75
Study Start Date: July 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: acoustic radiation force impulse (ARFI)
Imaging of liver and spleen using modified ultrasound
Device: ARFI ultrasound
ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures
Other Name: acoustic radiation force impulse

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.


  • 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.

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01644656

Contact: Guadalupe Garcia-Tsao, MD 2039325711 ext 2207

United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06511
Contact: Guadalupe Garcia-Tsao, MD   
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Guadalupe Garcia-Tsao    203-932-5711 ext 2206   
Sponsors and Collaborators
VA Connecticut Healthcare System
Principal Investigator: Guadalupe Garcia-Tsao, MD VA Connecticut Healthcare System
  More Information

Responsible Party: VA Connecticut Healthcare System Identifier: NCT01644656     History of Changes
Other Study ID Numbers: 01582
Study First Received: June 19, 2012
Last Updated: March 27, 2017

Keywords provided by VA Connecticut Healthcare System:
portal hypertension
diagnostic study

Additional relevant MeSH terms:
Liver Diseases
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Digestive System Diseases processed this record on September 21, 2017