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Completed

NCT Number: NCT03382119

Increased Liver Stiffness: A Study of Acoustic Radiation Force Impulse (ARFI) Elastography

The goal of this study is to determine if ultrasound tools can be used to detect liver stiffness. Acoustic radiation force impulse (ARFI) elastography and backscatter will be used to see if they can detect liver stiffness in different populations of patients with liver disease.

The study is measuring liver stiffness in pediatric patients aged 2-5 years. Patients either have had a Fontan cardiac surgery or have liver disease.

Ultrasound scanning takes images of the liver and has much lower risks for patients. ARFI elastography and other tools can be used to measure liver stiffness.

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Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

C.S. Mott Hospital

Ann Arbor, Michigan, 48109, United States

About this study

If patients have liver congestion, reversing it could prevent liver fibrosis, which cannot be treated. Liver fibrosis has serious health risks and is associated with a higher chance of developing liver cancer later in life.

Subjects from two patient populations will be enrolled in order to test ultrasound technologies. A total of 30 subjects between 2-5 years of age will be enrolled.

  • 15 children with increased liver stiffness due to the Fontan operation
  • 15 children with increased liver stiffness caused by Biliary Atresia.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 2-5 years
  • Children who are scheduled to have a Stage 3 Fontan cardiac operation (arm 1) AND Children who have chronic liver disease caused by biliary atresia (arm 2)
  • Patient must be receiving care at the University of Michigan CS Mott Children's Hospital
  • Parent/guardian must be willing to sign the study consent form

Exclusion criteria

  • For arm 1 subjects: pre-existing evidence of chronic liver disease (as defined by chronic elevation (over 4 weeks) of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or conjugated bilirubin to greater than two times the upper limit of normal
  • For arm 1 subjects: evidence of overt liver nodularity by conventional US imaging or evidence of portal vein or hepatic vein thrombosis (clots) by US Doppler exam

Treatment and study plan

Ultrasound with ARFI (acoustic radiation force impulse)

Device

This technology uses sound waves to measure the stiffness of tissue.

Other names: elastography

Ultrasound with backscatter imaging

Device

This ultrasound tool gathers data from the waves returning from imaged tissue.

Primary outcomes

  1. Shear wave speed

    Time frame: 15 minutes

    Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Children's Hospital Medical Center, Cincinnati

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 22, 2017
Registry last updated
Jun 2, 2020

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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