Shear Wave Sonoelastography in Pediatric Liver Fibrosis
Public ClinicalTrials.gov record NCT02372682. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
Shear Wave Sonoelastography for the Noninvasive Evaluation of Hepatic Fibrosis in the Pediatric Population
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Reliable methods of evaluating liver fibrosis using noninvasive techniques in the pediatric population are limited and inconclusive. Liver biopsy remains the gold standard; however, it requires sedation in pediatric patients, has a risk of hemorrhage, and provides unreliable results secondary to sampling error. Sonoelastography is a new method of evaluating liver disease that eliminates these pitfalls. There are 3 types of quantitative sonoelastography currently in use. Transient elastography is a non-imaging based technique used in adults to measure liver fibrosis in which a mechanical vibrator creates a low-frequency wave causing shear stress in the liver at a fixed depth. This technique does not work in small livers and, therefore, is not appropriate for pediatric patients. Acoustic Radiation Force Impulse Imaging (ARFI) and Shear Wave Imaging (SWE) use real-time ultrasonography and administer focused high-intensity, short-duration pulses to produce shear waves in the liver tissue. ARFI calculates the degree of tissue displacement and creates an elastogram or measurement of the stiffness of the sampled liver tissue without corresponding images. It is limited since only a small sample or region of interest (ROI) can be obtained, and it is unable to provide a corresponding elasticity map of the tissue. SWE is the newest elastography technique. It measures tiny displacements of tissue in a larger ROI with corresponding ultrasound images which provides a side by side image of the liver and color-coded elasticity map of the sampled tissue. Advantages include a larger ROI and simultaneous viewing of the selected region of interest which provides better anatomic detail with a corresponding color map of the tissue elasticity which may result in more accurate scoring of the stage of fibrosis. There are a few studies of ARFI in the pediatric population. Studies using SWE for evaluation of liver fibrosis are also few, and, all but one in adults. However, these studies have shown it to be an accurate method for liver fibrosis staging. Use of SWE in assessing liver fibrosis in pediatric patients may represent an accurate noninvasive alternative to liver biopsy in evaluating liver fibrosis as well as avoid the use of sedation.
Study identification
- NCT ID
- NCT02372682
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 171 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- Up to 18 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 10, 2015
- Primary completion
- May 30, 2018
- Completion
- May 30, 2018
- Last update posted
- Sep 11, 2019
2015 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Louis University School of Medicine | St Louis | Missouri | 63110 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02372682, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 11, 2019 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02372682 live on ClinicalTrials.gov.