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Completed

NCT Number: NCT04551716

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

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%.

Exclusion criteria

  • 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%).

Treatment and study plan

Primary outcomes

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

    Time frame: from October 2020 to june 2022

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Sep 16, 2020
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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