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

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ClinicalTrials.gov Identifier: NCT01644656
Recruitment Status : Recruiting
First Posted : July 19, 2012
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Portal Hypertension Chronic Liver Disease Device: ARFI ultrasound

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
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
Study Start Date : July 2012
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01644656


Contacts
Contact: Guadalupe Garcia-Tsao, MD 2039325711 ext 2207 Guadalupe.Garcia-Tsao@va.gov

Locations
United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06511
Contact: Guadalupe Garcia-Tsao, MD       guadalupe.garcia-tsao@yale.edu   
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Contact: Guadalupe Garcia-Tsao    203-932-5711 ext 2206    guadalupe.garcia-tsao@yale.edu   
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
Principal Investigator: Guadalupe Garcia-Tsao, MD VA Connecticut Healthcare System
More Information

Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT01644656     History of Changes
Other Study ID Numbers: 01582
First Posted: July 19, 2012    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: November 2017

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

Additional relevant MeSH terms:
Hypertension
Liver Diseases
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Digestive System Diseases