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

Liver Fibroses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03382119
• Other study ID #: HUM 130099
• Status: Completed
• Start date: April 11, 2018
• Est. completion date: July 19, 2019

Study information

• Verified date: May 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

1. 15 children with increased liver stiffness due to the Fontan operation

2. 15 children with increased liver stiffness caused by Biliary Atresia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 19, 2019
• Est. primary completion date: July 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Cirrhosis
• Liver Fibroses

Intervention

Device:
• Ultrasound with ARFI (acoustic radiation force impulse)
This technology uses sound waves to measure the stiffness of tissue.
• Ultrasound with backscatter imaging
This ultrasound tool gathers data from the waves returning from imaged tissue.

Locations

Country	Name	City	State
United States	C.S. Mott Hospital	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shear wave speed	Shear wave speed is a measure of stiffness of liver tissue expressed in units of m/s	15 minutes