Back to resultsNon-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
Primary Purpose
Portal Hypertension, Chronic Liver Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ARFI ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Portal Hypertension focused on measuring portal hypertension, cirrhosis, ARFI, diagnostic study
Eligibility 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
Sites / Locations
- Yale-New Haven Hospital
- VA Connecticut Healthcare System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
acoustic radiation force impulse (ARFI)
Arm Description
Imaging of liver and spleen using modified ultrasound
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT01644656
First Posted
June 19, 2012
Last Updated
September 4, 2018
Sponsor
VA Connecticut Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01644656
Brief Title
Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Portal Hypertension, Chronic Liver Disease
Keywords
portal hypertension, cirrhosis, ARFI, diagnostic study
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Arm Title
acoustic radiation force impulse (ARFI)
Arm Type
Experimental
Arm Description
Imaging of liver and spleen using modified ultrasound
Intervention Type
Device
Intervention Name(s)
ARFI ultrasound
Other Intervention Name(s)
acoustic radiation force impulse
Intervention Description
ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures
Primary Outcome Measure Information:
Title
correlation of acoustic radiation force impulse (ARFI) measurement of organ stiffness with hepatic venous pressure gradient (HVPG)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guadalupe Garcia-Tsao, MD
Organizational Affiliation
VA Connecticut Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale-New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
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