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

Portal Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01644656
• Other study ID #: 01582
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: VA Connecticut Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Liver Disease
• Hypertension
• Hypertension, Portal
• Liver Diseases
• Portal Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Both outcome measurements (ARFI measurements and HVPG) will be obtained within an average time frame of 4-8 hours