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

NCT03382119 | Completed

• 1 other identifier: HUM 130099
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Fibroses

Keywords

liver stiffness Fontan

Outcome Measures

Primary Outcomes (1)

• Shear wave speed

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

  15 minutes

Study Arms (2)

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.

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

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.

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

Interventions

Ultrasound with ARFI (acoustic radiation force impulse) DEVICE

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

Also known as: elastography

Patients having Fontan cardiac surgery; Patients with Liver disease

Ultrasound with backscatter imaging DEVICE

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

Patients having Fontan cardiac surgery; Patients with Liver disease

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients will either be scheduled for a Stage 3 Fontan cardiac operation or have chronic liver disease caused by biliary atresia.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Children's Hospital Medical Center, Cincinnati: collaborator

Study Sites (1)

C.S. Mott Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Ultrasonography; Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Frank DiPaola, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 13, 2017
• First Posted: December 22, 2017
• Study Start: April 11, 2018
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: June 2, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)