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Completed

NCT Number: NCT01644656

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

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.

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Key information

Conditions

Portal Hypertension Chronic Liver Disease Digestive System Diseases Disease Fibrosis Hypertension, Portal Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale-New Haven Hospital, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARFI ultrasound

Device

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

Other names: acoustic radiation force impulse

Primary outcomes

  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).

Sponsors and collaborators

Lead sponsor

VA Connecticut Healthcare System

Fed

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Jul 19, 2012
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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