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Shear Wave Sonoelastography in Pediatric Liver Fibrosis

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ClinicalTrials.gov Identifier: NCT02372682
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Shannon G. Farmakis, M.D., St. Louis University

Brief 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 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.


Condition or disease Intervention/treatment
Sonoelastography Elastography Elastograms Liver Fibrosis Hepatic Fibrosis Cirrhosis Pediatrics Device: Shear wave sonoelastography

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 172 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Shear Wave Sonoelastography for the Noninvasive Evaluation of Hepatic Fibrosis in the Pediatric Population
Actual Study Start Date : May 11, 2015
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Test

Any pediatric patient (0-18 years of age) with known liver disease in whom a liver biopsy is to be performed as standard of care to assess the degree of fibrosis will also undergo an abdominal ultrasound to evaluate the liver.

Underlying diagnoses include but are not limited to 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).

Device: Shear wave sonoelastography
Sonoelastography is to be performed on the liver.

Control
Any pediatric patient (0-18 years of age) undergoing evaluation with an abdominal ultrasound as standard of care for evaluation for a diagnosis other than liver disease and in whom the US shows a normal liver, gallbladder, pancreas, spleen, and biliary tree will then be asked to enroll in the research study by undergoing shear wave elastography.
Device: Shear wave sonoelastography
Sonoelastography is to be performed on the liver.




Primary Outcome Measures :
  1. Shear wave sonoelastography for the noninvasive evaluation of hepatic fibrosis in the pediatric population [ Time Frame: 2 years ]
    To determine if shear wave elastography represents an alternative noninvasive and accurate method of detecting and staging liver fibrosis in children.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

The test population is 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 but are not limited to 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).

The control population is any pediatric patient (0-18 years of age) undergoing an abdominal ultrasound for reasons other than liver disease and in whom the US shows a normal liver, gallbladder, pancreas, spleen, and biliary tree.

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372682


Locations
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United States, Missouri
St. Louis University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
St. Louis University
Investigators
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Principal Investigator: Shannon Farmakis, MD Assistant Professor, Saint. Louis University

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Responsible Party: Shannon G. Farmakis, M.D., Assistant Professor, St. Louis University
ClinicalTrials.gov Identifier: NCT02372682     History of Changes
Other Study ID Numbers: 25138
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: June 2018

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases