Ultrasound Method to Measure Fibrosis of the Liver in Children



Status:Completed
Conditions:Hospital, Gastrointestinal, Gastrointestinal, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Other
Healthy:No
Age Range:5 - 18
Updated:4/2/2016
Start Date:June 2010
End Date:March 2015
Contact:Uzma Shah, MD, FAAP
Email:USHAH@partners.org
Phone:617-726-0319

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Sonoelastography: Ultrasound Method to Measure Fibrosis of the Liver in Children

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate
quantitative measurements that can be used to stage liver fibrosis in pediatric patients
with chronic liver disease.

Specific Aims:

1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver
disease who will undergo nonfocal liver biopsy as part of their routine clinical care.

2. To assess the sensitivity and specificity of sonoelastography for the detection and
staging of liver fibrosis.

3. To obtain sonoelastography values of the liver in healthy children (control subjects).


Inclusion criteria:

- Patients scheduled for random liver biopsy for routine staging of liver fibrosis

- Pediatric patients patients (ages 5-18)

- Girls or boys

- Suspected liver disease

- Consent to participate in the study

Inclusion criteria for Controls:-

- Patients scheduled for ultrasound examination (other than a liver biopsy)

- Pediatric patients (ages 5-18) without known liver disease

- Girls or boys

- No known liver disease

- Consent to participate in the study

Exclusion criteria:

- Pregnancy

- Acute illness/cognitive impairment resulting in inability to cooperate with
ultrasound

- Patients that do not consent to ultrasound guided liver biopsy.

- Contraindications to liver biopsy (e.g. low platelets defined as a platelet count of
less than 50,000, and hemophilia/coagulopathy as an INR higher than 1.5.)
We found this trial at
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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