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NCT02372682 · ClinicalTrials.gov registry record
Shear Wave Sonoelastography in Pediatric Liver Fibrosis
A clinical trial, sponsored by St. Louis University.
- Completed
- Registry status
- 171
- Enrollment target
NCT02372682: Completed study, sponsored by St. Louis University.
NCT02372682 is a clinical trial that has completed, run by St. Louis University. The registered enrollment target is 171 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02372682 has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- 171 participants
- Enrollment target
Study Summary
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 h
Primary Outcome
METAVIR score is a tool used to measure fibrosis as seen on liver biopsy and scored to describe liver disease progress and prognosis.
Interventions
- DEVICE Shear wave sonoelastography
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2015-05-11 |
| Est. Completion | 2018-05-31 |
What the finished NCT02372682 record still lists
NCT02372682 is an observational study that tracks outcomes without assigning an intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Shear wave sonoelastography is the first listed.
NCT02372682 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02372682 about?
NCT02372682 is a clinical study titled "Shear Wave Sonoelastography in Pediatric Liver Fibrosis". 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 sam...
What is the current status of trial NCT02372682?
This trial is currently completed. The enrollment target is 171 participants. The study started on 2015-05-11. Estimated completion is 2018-05-31.
What interventions are being tested in trial NCT02372682?
The interventions under investigation include: Shear wave sonoelastography (DEVICE).
Who is sponsoring clinical trial NCT02372682?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
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