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

This study is not yet open for participant recruitment.

Verified July 2012 by VA Connecticut Healthcare System

Sponsor:

Information provided by (Responsible Party):

VA Connecticut Healthcare System

ClinicalTrials.gov Identifier:

NCT01644656

First received: June 19, 2012

Last updated: July 16, 2012

Last verified: July 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 19, 2012

Last Updated Date

July 16, 2012

Start Date ^ICMJE

July 2012

Estimated Primary Completion Date

June 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01644656 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

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 Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Portal Hypertension
Chronic Liver Disease

Intervention ^ICMJE

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

Study Arm (s)

Experimental: acoustic radiation force impulse (ARFI)

Imaging of liver and spleen using modified ultrasound

Intervention: Device: ARFI ultrasound

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2016

Estimated Primary Completion Date

June 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Guadalupe Garcia-Tsao, MD

2039325711 ext 2207

Guadalupe.Garcia-Tsao@va.gov

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01644656

Other Study ID Numbers ^ICMJE

01582

Has Data Monitoring Committee

Responsible Party

VA Connecticut Healthcare System

Study Sponsor ^ICMJE

VA Connecticut Healthcare System

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Guadalupe Garcia-Tsao, MD

VA Connecticut Healthcare System

Information Provided By

VA Connecticut Healthcare System

Verification Date

July 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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