Shear Wave Sonoelastography in Pediatric Liver Fibrosis

NCT02372682 | Completed Results

• 1 other identifier: 25138
• Study Type: observational
• Target: 171
• Locations: 1 country
• Sites: 1

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.

Conditions

Sonoelastography; Elastography; Elastograms; Liver Fibrosis; Hepatic Fibrosis; Cirrhosis; Pediatrics

Outcome Measures

Primary Outcomes (2)

• 2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on METAVIR Scoring System

  METAVIR score is a tool used to measure fibrosis as seen on liver biopsy and scored to describe liver disease progress and prognosis.

  2 years

• 2D-SWE Measurements' Capability of Predicting Stages of Fibrosis Based on Ishak Scoring System

  Ishak is a tool used to evaluate liver fibrosis via liver biopsy to report severity and prognosis of liver disease, specifically hepatitis.

  2 years

Study Arms (2)

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

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

Interventions

Shear wave sonoelastography DEVICE

Sonoelastography is to be performed on the liver.

Control; Test

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

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.

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

St. Louis University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Liver Cirrhosis; Fibrosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anna Hardy, Research Nurse Coordinator
• Organization: Saint Louis University

anna.hardy@health.slu.edu

314-268-5785

Study Officials

• Shannon Farmakis, MD

  Assistant Professor, Saint. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 20, 2015
• First Posted: February 26, 2015
• Study Start: May 11, 2015
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: September 12, 2019
• Results First Posted: September 12, 2019

Record last verified: 2019-08

Locations

US (1)