Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis

March 27, 2023 updated by: Hong You, Beijing Friendship Hospital

Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis in Chronic Hepatitis B or NAFLD Patients

Totals of 400 chronic hepatitis B or non-alcoholic fatty liver disease (NAFLD) patients with or without cirrhosis will be enrolled. Patients' clinical characteristics, including alanine aminotransferase, aspartic aminotransferase, total bilirubin, direct bilirubin, indirect bilirubin, triglyceride and total cholesterol, hepatitis B surface antigen, steatosis, and liver stiffness measurement will be collected. The consistence of liver fibrosis and steatosis assessment between Hepatus and FibroScan will be evaluated in this study.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Select A State Or Province
      • Beijing, Select A State Or Province, China, 100050
        • Recruiting
        • Yameng Sun
        • Principal Investigator:
          • Hong You, Doctor
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease.

Description

Inclusion Criteria:

  • Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease;
  • Age above 18 years;
  • Signature of informed consent.

Exclusion Criteria:

  • Patients with HCV and/or other viral hepatitis, autoimmune liver disease, alcoholic liver disease, genetic liver disease or other chronic liver diseases;
  • Patients with decompensated cirrhosis;
  • Patients with serum total bilirubin level higher than 51 umol/L;
  • Patients with liver malignant lesion, hemangiomas, giant liver cysts and other liver lesions;
  • Patients with HIV infections;
  • Patients after liver transplantation or TIPS;
  • Pregnant women;
  • Patients with Budd-Chiari syndrome, chronic congestive heart failure, constrictive pericarditis or other liver congestion lesions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode.
Time Frame: 1 to 3 years
Consistency of liver stiffness and steatosis between Hepatus and FibroScan.
1 to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Consistency of liver stiffness and steatosis results between Hepatus in continuous measurement mode and FibroScan in single detection mode through the respective localization methods.
Time Frame: 1 to 3 years
The localization method of Hepatus is the real-time two-dimensional image guiding system, which is manually location in FibroScan.
1 to 3 years
Consistency of liver stiffness and steatosis results between Hepatus and FibroScan in single detection mode.
Time Frame: 1 to 3 years
The localization methods include the respective localization methods in Hepatus and FibroScan, and manually locating.
1 to 3 years
Comparison of measurement performance in Hepatus under continuous detection mode and in FibroScan through single detection mode.
Time Frame: 1 to 3 years
Evaluation of measurement performance includes the rate of successful detection, time taken for validated detection, stability of liver stiffness measurement and controlled attenuation parameter.
1 to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 29, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

November 27, 2022

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

March 28, 2023

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YYYXYJ-2022-095

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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