Liver Fibrosis, Liver Inflammation
Conditions
Brief summary
ARFI (Ultrasound-based Acoustic Radiation Force Impulse) will be used during ultrasound guided needle biopsy of the liver of children.
Detailed description
A new technique based on ultrasound, known as Acoustic Radiation Force Impulse (ARFI) imaging is performed using standard approved ultrasound machines and transducers. The sound waves or impulses are generated in a different pattern and offer information on the stiffness of the tissue. This new technique will be evaluated for usefulness in diagnosing different liver conditions.
Interventions
DEVICEUltrasound-Based Acoustic Radiation Force Impulse (ARFI)
Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively.
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or younger * Scheduled to have a needle biopsy of the liver at 1. C.S. Mott Children's Hospital or 2. Dept. of Radiology at the Univ. of Michigan Hospital * Scheduled to have an abdominal ultrasound to evaluate your liver (with no known liver disease)
Exclusion criteria
* None to list
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score | 10 minutes | Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures. Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis. |
Countries
United States
Participant flow
Recruitment details
Pediatric patients aged 18 and younger were scheduled for a liver biopsy at a large pediatric hospital between 2012 and 2014. A total of 62 patients were recruited and enrolled. Patients and their parents gave consent/assent for the study.
Participants by arm
| Arm | Count |
|---|---|
| Ultrasound-based Acoustic Radiation Force Impulse (ARFI) 62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy for known or suspected (non-neoplastic) liver disease were included in this study. Subjects were between 0-18 years of age. | 62 |
| Total | 62 |
Baseline characteristics
| Characteristic | Ultrasound-based Acoustic Radiation Force Impulse (ARFI) |
|---|---|
| Age, Categorical <=18 years | 62 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 8.0 years |
| Region of Enrollment United States | 62 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score
Tissue shear wave speed is positively correlated to a material's/tissue's stiffness and can be noninvasively measured by ultrasound. The relationship between liver shear wave speed and liver histologic fibrosis score were assessed using 2 different ultrasound methods. Liver shear wave speed as obtained using 2 different ultrasound methods served as our primary outcome measures. Note, the histologic scoring system (Ishak) ranged from 0 to 6, where 0 = no fibrosis and 6 = cirrhosis.
Time frame: 10 minutes
Population: 49 pediatric subjects underwent successful (diagnostic) liver ARFI/VTQ) assessment and liver histologic fibrosis scoring. 13 subjects had non-diagnostic ARFI/VTQ exams.~48 pediatric subjects underwent successful (diagnostic) liver ARFI/VTIQ) assessment and liver histologic fibrosis scoring. 14 subjects had non-diagnostic ARFI/VTIQ exams.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children Undergoing Diagnostic ARFI/VTQ and Fibrosis Scoring | ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score | 1.69 m/s | Standard Deviation 0.42 |
| Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring | ARFI/VTQ and ARFI/VTIQ Liver Shear Wave Speed vs. Liver Histologic Fibrosis Score | 2.01 m/s | Standard Deviation 0.58 |
Comparison: Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.p-value: <0.0001Pearson Correlation
Comparison: Continuous data were summarized using means and standard deviations. The relationship between ARFI (VTIQ) liver shear wave speed and liver histologic fibrosis score were assessed using Pearson correlation. No a priori power analysis was performed.p-value: <0.0001Pearson Correlation