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

NCT ID: NCT03382119

Last Updated: 2020-06-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-11
• Study Completion Date: 2019-07-19

Brief 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.

Detailed 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.

Conditions

Liver Fibroses

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients having Fontan cardiac surgery

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.

Ultrasound with ARFI (acoustic radiation force impulse)

Intervention Type: DEVICE

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

Ultrasound with backscatter imaging

Intervention Type: DEVICE

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

Patients with Liver disease

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.

Ultrasound with ARFI (acoustic radiation force impulse)

Intervention Type: DEVICE

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

Ultrasound with backscatter imaging

Intervention Type: DEVICE

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

Interventions

Ultrasound with ARFI (acoustic radiation force impulse)

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

Intervention Type: DEVICE

Ultrasound with backscatter imaging

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

Intervention Type: DEVICE

Other Intervention Names

elastography

Eligibility Criteria

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Frank DiPaola

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank DiPaola, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

C.S. Mott Hospital

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

HUM 130099

Identifier Type: -

Identifier Source: org_study_id