Sonoelastography: Ultrasound Method to Measure Liver Fibrosis

NCT01747772 | Completed Results DMC

• 1 other identifier: 2009P002791
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To assess the sensitivity and specificity of sonoelastography for the detection and staging of liver fibrosis
3. 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

Keywords

Non-focal Liver Disease; Fibrosis; Shear Wave Sonoelastography; Metavir Liver Fibrosis Grading

Outcome Measures

Primary Outcomes (1)

• Liver Elasticity Value Measured Using Sonoelastography (SE)

  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.

  Day 1

Study Arms (1)

Shear Wave Sonoelastography for Fibrosis Assessment

EXPERIMENTAL

Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.

Device: Shear Wave Sonoelastography

Interventions

Shear Wave Sonoelastography DEVICE

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.

Also known as: Supersonic Aixplorer

Shear Wave Sonoelastography for Fibrosis Assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (age 18 or older)
• Men or women
• Suspected diffuse liver disease
• Consent to participate in the study

You may not qualify if:

• Pregnancy
• Acute illness/cognitive impairment resulting in inability to cooperate with ultrasound.
• Patients that do not consent to ultrasound or sonoelastography.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Samir AE, Dhyani M, Vij A, Bhan AK, Halpern EF, Mendez-Navarro J, Corey KE, Chung RT. Shear-wave elastography for the estimation of liver fibrosis in chronic liver disease: determining accuracy and ideal site for measurement. Radiology. 2015 Mar;274(3):888-96. doi: 10.1148/radiol.14140839. Epub 2014 Nov 13.

  PMID: 25393946 BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Hepatitis C; Coinfection; Hepatitis B; Chemical and Drug Induced Liver Injury; Fibrosis

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Hepadnaviridae Infections; DNA Virus Infections; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Anthony E. Samir MD
• Organization: Division of Abdominal Imaging and Interventional Radiology, Massachusetts General Hospital

asamir@partners.org

Study Officials

• Anthony E Samir, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Ultrasound Imaging Services Assistant Radiologist, Abdominal Imaging & Intervention Massachusetts General Hospital

Study Record Dates

• First Submitted: October 31, 2012
• First Posted: December 12, 2012
• Study Start: February 1, 2010
• Primary Completion: February 14, 2014
• Study Completion: February 14, 2014
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Locations

US (1)