Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis

Sponsor

Beijing Friendship Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05786963

Collaborator

(none)

400

Enrollment

Location

15.1

Anticipated Duration (Months)

26.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis b Non-Alcoholic Fatty Liver Disease

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Dec 29, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Outcome Measures

Primary Outcome Measures

Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode. [1 to 3 years]
Consistency of liver stiffness and steatosis between Hepatus and FibroScan.

Secondary Outcome Measures

Consistency of liver stiffness and steatosis results between Hepatus in continuous measurement mode and FibroScan in single detection mode through the respective localization methods. [1 to 3 years]
The localization method of Hepatus is the real-time two-dimensional image guiding system, which is manually location in FibroScan.
Consistency of liver stiffness and steatosis results between Hepatus and FibroScan in single detection mode. [1 to 3 years]
The localization methods include the respective localization methods in Hepatus and FibroScan, and manually locating.
Comparison of measurement performance in Hepatus under continuous detection mode and in FibroScan through single detection mode. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.