Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis

Recruiting

• Conditions: Chronic Hepatitis b; Non-Alcoholic Fatty Liver Disease

• Registration Number: NCT05786963
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-27
• Study Start: 2022-12-29
• Status Verified: 2023-03
• Study First Submitted QC: 2023-03-27
• Last Update Submitted: 2023-03-27
• Study First Posted: 2023-03-28
• Last Update Posted: 2023-03-28
• Primary Completion: 2023-12
• Study Completion: 2024-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Yameng Sun; 🇨🇳 Beijing, Select A State Or Province, China