Shear Wave Sonoelastography in Pediatric Liver Fibrosis

Completed

Conditions studied: Sonoelastography, Elastography, Elastograms, Liver Fibrosis, Hepatic Fibrosis, Cirrhosis, Pediatrics

In brief

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.

Key facts

Study ID

NCT02372682

Run by

St. Louis University

People needed

171

Starts

2015-05-11

Expected to finish

2018-05-31

Last updated by the study team

2019-09-12

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Any pediatric patient (0-18 years of age) with known liver disease with plans to undergo a liver biopsy within 1 month of ultrasound exam. Underlying diagnoses include biliary atresia, congenital fibrosis-cholestasis, Alagille syndrome, Caroli's disease, choledochal cyst, alpha-1-antitrypsin deficiency, progressive familial intrahepatic cholestasis (PFIC), viral hepatitis, glycogenosis, fructosemia, Wilson disease, cystic fibrosis, autosomal recessive polycystic kidney disease (ARPCKD), mesenterico-caval shunt, post liver transplant, and nonalcoholic steatohepatitis (NASH). Written informed consent from parent or legal guardian. Written informed assent from the child.

You may not qualify if…

• Inconclusive biopsy results. Patient not cooperative for the ultrasound exam. Failure to give informed consent. No biopsy results within allotted time frame. Poor acoustic window in which to perform sonoelastography.

Where it is running

• St. Louis University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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