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NCT06097338

Quantitative US for Evaluation of Hepatic Steatosis in MAFLD With UDFF

Sponsor: Qianfoshan Hospital

View on ClinicalTrials.gov

Summary

Ultrasound Derived Fat Fraction (UDFF) Evaluation of Metabolic Related Fatty Liver Disease (MAFLD) in obesity Patients Metabolic fatty liver disease (MAFLD), formerly known as Nonalcoholic Fatty Liver Disease (NAFLD), is the most common chronic liver disease in the world at present, with a incidence rate of about 30%. In the United States, NAFLD is the third leading cause of hepatocellular carcinoma, and early assessment and diagnosis of liver steatosis characteristics are crucial for timely treatment or intervention to reduce the risk of liver fibrosis and inhibit disease progression. Liver biopsy is considered as the "gold standard" for evaluating, grading, and determining inflammatory activity of liver steatosis and fibrosis. However, liver biopsy are invasive and pathological evaluation differences among observers, which makes it difficult to widely use and repeat, especially for dynamic evaluation of patients during the treatment process. Ultrasound Derviced Fat Fraction (UDFF) is a unique technology for non-invasive quantification of liver fat content, which is equipped on the Siemens ACUSON Sequoia ultrasound system. UDFF is calculated from two parameter values: attenuation coefficient (AC) and backscatter coefficient (BSC). SWE (shear wave elastography) is becoming widely used, and is recommended for the evaluation of liver fibrosis by some guidelines in patients with chronic liver diseases, such as viral hepatitis. These two technologies (UDFF+SWE) can be achieved on the same probe, and this detection technology is non-invasive, painless, simple, and reliable. Bariatric surgery (BS), also known as metabolic weight loss surgery, is currently recognized as the most significant and long-lasting method for treating obesity. It can significantly improve obesity related comorbidities, as well as long-term improvement in postoperative quality of life and mental state. This study will aim on analysis of the liver ultrasound characteristics of patients who plan to undergo bariatric surgery. By using UDFF and elastic shear wave technology (UDFF+SWE), a new non-invasive ultrasound evaluation method for MAFLD grading diagnosis of simple fatty liver, fatty hepatitis, liver fibrosis, and related cirrhosis will be proposed, and the incidence and risk factors of MAFLD in overweight and obese patients will be explored, The reversal effect of weight loss therapy on MAFLD in obese patients.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2023-10

Completion Date

2026-09

Last Updated

2023-10-24

Healthy Volunteers

Yes

Interventions

PROCEDURE

bariatric surgery (BS)

bariatric surgery (BS) is a very attractive choice for severely obese patients. After bariatric surgery, long-term weight loss (15%-25%) and diabetes remission can occur \[16\], as well as long-term mortality, cardiovascular events and tumor occurrence \[17\]. Regardless of the surgical procedure used for weight loss surgery, studies have shown that weight loss surgery can significantly reduce the liver NAFLD activity score (from 5 to 1), and 33.8% of patients have reduced liver fibrosis \[18\]. The follow-up results for a longer period of time (10 years) also indicate that weight loss surgery significantly reduces the occurrence of major adverse outcomes related to liver cirrhosis, liver cancer, liver transplantation, and liver related deaths