Comparison of Hepatus and FibroScan for Evaluation of Fibrosis and Steatosis

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05786963
• Other study ID #: YYYXYJ-2022-095
• Status: Recruiting
• Start date: December 29, 2022
• Est. completion date: April 2024

Study information

• Verified date: March 2023
• Source: Beijing Friendship Hospital
• Contact: Hong You, Doctor
• Phone: 86-010-63139019
• Email: youhong30[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: April 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hepatitis b
• Fatty Liver
• Fibrosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
China	Yameng Sun	Beijing	Select A State Or Province

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consistency of liver stiffness and steatosis results in the same location between Hepatus in continuous measurement mode and FibroScan in single detection mode.	Consistency of liver stiffness and steatosis between Hepatus and FibroScan.	1 to 3 years
Secondary	Consistency of liver stiffness and steatosis results between Hepatus in continuous measurement mode and FibroScan in single detection mode through the respective localization methods.	The localization method of Hepatus is the real-time two-dimensional image guiding system, which is manually location in FibroScan.	1 to 3 years
Secondary	Consistency of liver stiffness and steatosis results between Hepatus and FibroScan in single detection mode.	The localization methods include the respective localization methods in Hepatus and FibroScan, and manually locating.	1 to 3 years
Secondary	Comparison of measurement performance in Hepatus under continuous detection mode and in FibroScan through single detection mode.	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