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Sonoelastography: Ultrasound Method to Measure Liver Fibrosis

NCT01747772 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2017-06-14

Study results available
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Summary

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

1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver disease who will undergo non-focal 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 evaluate the effect of steatosis and inflammation on the estimation of liver fibrosis using sonoelastography

Conditions

  • Chronic Liver Disease
  • Non-Alcoholic Fatty Liver Disease
  • Hepatitis C Virus (HCV) Coinfection
  • Hepatitis B Virus (HBV)
  • Drug-Induced Liver Injury

Interventions

DEVICE

Shear Wave Sonoelastography

Shear Wave sonoelastography (SWE) as an ultrasound technique to measure liver fibrosis was performed on patients scheduled for non-focal liver biopsy. Results were compared with pathological score from liver biopsy.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Anthony E Samir, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2014-02-14
Completion
2014-02-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01747772 on ClinicalTrials.gov