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

University of Michigan

Status: Completed

Conditions: Liver Fibroses

Treatments: Device: Ultrasound with ARFI (acoustic radiation force impulse); Device: Ultrasound with backscatter imaging

Study type: Observational

Funder types: Other

Identifiers

NCT03382119

HUM 130099

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

25 participants in 2 patient groups

Patients having Fontan cardiac surgery

Description:

This group includes pediatric patients, aged 2-5 years, who have had a Fontan operation. This surgery corrects a heart defect found at birth in which the heart has only one ventricle. Patients will have an Ultrasound with ARFI imaging.

Treatment:

Device: Ultrasound with backscatter imaging

Device: Ultrasound with ARFI (acoustic radiation force impulse)

Patients with Liver disease

Description:

This group includes pediatric patients, aged 2-5 years, who have chronic liver disease caused by biliary atresia. Patients will have an Ultrasound with ARFI imaging.

Treatment:

Device: Ultrasound with backscatter imaging

Device: Ultrasound with ARFI (acoustic radiation force impulse)