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

Assessment of Metabolic Associated Fatty Liver Disease (MAFLD) in Chinese Population Using ATI / SWE / SWD: a Prospective Multicenter Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04551716

Enrollment

448

Registered

2020-09-16

Start date

2020-09-10

Completion date

2022-08-31

Last updated

2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

1. being a Chinese citizen aged 18 to 85 years; 2. meeting the diagnostic criteria for MAFLD; 3. willing and able to provide informed consent; 4. having a platelet count of at least 50 × 109/L and prothrombin activity of ≥50%.

Exclusion criteria

1. The pregnant. 2. Patients who have received or are undergoing systemic chemotherapy. 3. 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. 4. Those who re fuse to sign informed consent; 5. There was a significant risk of bleeding (platelet \< 50x109 / L, prothrombin activity \< 50%).

Design outcomes

Primary

Measure	Time frame
Correlation between ATI / SWD / SWE parameters and the degree of steatosis, inflammation and fibrosis in MAFLD patients	from October 2020 to june 2022

Countries

China

Outcome results