Noninvasive Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population

NCT04551716 | Completed

• 1 other identifier: S2020-298-01-01
• Study Type: observational
• Target: 448
• Locations: 1 country
• Sites: 1

Brief Summary

Attenuation imaging (ATI) technology independently developed by Canon medical is a non-invasive examination technology for quantitative detection and analysis of liver steatosis. The technique is simple, rapid and quantitative diagnosis, and is suitable for screening and popularization of early liver steatosis in MAFLD. As noninvasive and effective detection measures of liver inflammation and liver fibrosis, SWD and SWE are more and more widely used in the quantitative diagnosis of liver inflammation and fibrosis. Therefore, ATI combined with SWD / SWE detection can quantitatively diagnose different pathological stages (steatosis, necrotizing inflammation and liver fibrosis) in the development of MAFLD, so as to provide an important basis for treatment.

Conditions

Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

Outcome Measures

Primary Outcomes (1)

• Correlation between ATI / SWD / SWE parameters and the degree of steatosis, inflammation and fibrosis in MAFLD patients

  from October 2020 to june 2022

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

According to the results of HBV surface antigen, the patients were divided into two subgroups: (1) HBV surface antigen negative group: pure mafld group; (2) HBV surface antigen positive group: mafld combined with hepatitis B group

You may qualify if:

• being a Chinese citizen aged 18 to 85 years;
• meeting the diagnostic criteria for MAFLD;
• willing and able to provide informed consent;
• having a platelet count of at least 50 × 109/L and prothrombin activity of ≥50%.

You may not qualify if:

• The pregnant.
• Patients who have received or are undergoing systemic chemotherapy.
• Patients with hepatitis C, alcoholic liver disease (more than 5 years of drinking history, equivalent to alcohol volume ≥ 40g / D in male and ≥ 20g / D in female), drug-induced liver disease or autoimmune hepatitis.
• Those who re fuse to sign informed consent;
• There was a significant risk of bleeding (platelet \< 50x109 / L, prothrombin activity \< 50%).

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Study Officials

• Ping Liang, MD

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 16, 2020
• Study Start: September 10, 2020
• Primary Completion: June 30, 2022
• Study Completion: August 31, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

CN (1)