Ultrasound Method to Measure Fibrosis of the Liver in Children

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2015-03-31

Brief Summary

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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:

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

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Detailed Description

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Conditions

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Chronic Liver Disease Non-Alcoholic Fatty Liver Disease HCV Coinfection HBV Drug-Induced Liver Injury

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Shear Wave Sonoelastography, Fibrosis stage

Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.

Group Type EXPERIMENTAL

Shear Wave sonoelastography

Intervention Type DEVICE

Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score of fibrosis from liver biopsy.

Interventions

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Shear Wave sonoelastography

Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score of fibrosis from liver biopsy.

Intervention Type DEVICE

Other Intervention Names

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Supersonic Aixplorer

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for random liver biopsy for routine staging of liver fibrosis
* Pediatric patients patients (ages 1-21)
* Girls or boys
* Suspected 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.)

Minimum Eligible Age

1 Year

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No