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Sonoelastography: Ultrasound Method to Measure Liver Fibrosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01747772
First Posted: December 12, 2012
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Anthony Samir, Massachusetts General Hospital
  Purpose

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

Condition Intervention
Chronic Liver Disease Non-Alcoholic Fatty Liver Disease Hepatitis C Virus (HCV) Coinfection Hepatitis B Virus (HBV) Drug-Induced Liver Injury Device: Shear Wave Sonoelastography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Biopsy specimens were assessed via Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) criteria by a pathologist who was blinded to the shear-wave elastography (SWE) values.
Primary Purpose: Diagnostic
Official Title: Evaluate the Utility of Shear Wave Sonoelastography as a Tool to Measure Liver Fibrosis Grade

Resource links provided by NLM:


Further study details as provided by Anthony Samir, Massachusetts General Hospital:

Primary Outcome Measures:
  • Liver Elasticity Value Measured Using Sonoelastography (SE) [ Time Frame: Day 1 ]
    Liver elasticity/stiffness was assessed via SE and compared against results of liver biopsy as read by a single pathologist using the Meta-analysis of Histological Data in Viral Hepatitis (METAVIR) 5-point scale (F [Fibrosis]0=no fibrosis, F1=portal fibrosis without septa, F2=portal fibrosis with few septa, F3=numerous septa without cirrhosis, and F4=cirrhosis). Using SE, fibrosis is measured in kilopascals (kPa) with normal values equaling approximately 5.5 kPa (normal liver stiffness ranges between 3.3-7.8 kPa). Significant Fibrosis (F3): = or > 7.6 kPa, Cirrhosis (F4): = or > 9.0- 26 kPa. A higher number corresponds to an increase in stiffness and hepatic fibrosis.


Enrollment: 180
Actual Study Start Date: February 2010
Study Completion Date: February 14, 2014
Primary Completion Date: February 14, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Shear Wave Sonoelastography for Fibrosis Assessment
Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
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.
Other Name: Supersonic Aixplorer

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (age 18 or older)
  • Men or women
  • Suspected diffuse 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 or sonoelastography.
  Contacts and Locations
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): NCT01747772


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Anthony E Samir, MD Massachusetts General Hospital
  More Information

Publications:
Responsible Party: Anthony Samir, Associate Director, Ultrasound Imaging Services Assistant Radiologist, Abdominal Imaging & Intervention Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01747772     History of Changes
Other Study ID Numbers: 2009P002791
First Submitted: October 31, 2012
First Posted: December 12, 2012
Results First Submitted: March 23, 2017
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017

Keywords provided by Anthony Samir, Massachusetts General Hospital:
Non-focal Liver Disease
Fibrosis
Shear Wave Sonoelastography
Metavir Liver Fibrosis Grading

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Fibrosis
Hepatitis B
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Cirrhosis
Coinfection
Chemical and Drug Induced Liver Injury
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
Infection
Parasitic Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Poisoning
Liver Extracts
Hematinics