Clinical trial NCT05786963: Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis
Official title: Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis in Chronic Hepatitis B or NAFLD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis b
Non-Alcoholic Fatty Liver Disease
Keywords: Chronic Hepatitis b
Non-alcoholic Fatty Liver Disease
Liver fibrosis/cirrhosis
Steatosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with or without cirrhosis diagnose as chronic hepatitis B or non-alcoholic fatty liver disease.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode.
timeFrame: 1 to 3 years
Secondary outcomes:
measure: Consistency of liver stiffness and steatosis results between Hepatus in continuous measurement mode and FibroScan in single detection mode through the respective localization methods.
timeFrame: 1 to 3 years
measure: Consistency of liver stiffness and steatosis results between Hepatus and FibroScan in single detection mode.
timeFrame: 1 to 3 years
measure: Comparison of measurement performance in Hepatus under continuous detection mode and in FibroScan through single detection mode.
timeFrame: 1 to 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Yameng Sun
state: Select A State Or Province
Study officials:
affiliation: Beijing Friendship Hospital
name: Hong You, doctor
role: PRINCIPAL_INVESTIGATOR
References: