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

Completed

• Conditions: Metabolic-dysfunction-associated Fatty Liver Disease (MAFLD)

• Registration Number: NCT04551716
• Lead Sponsor: Chinese PLA General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-10
• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-16
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-31
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-13
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 448

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%).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China