Quantitative US for Evaluation of Hepatic Steatosis in MAFLD With UDFF
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- The combined detection of UDFF and SWE based on ultrasound images
研究概览
简要总结
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.
详细描述
- Research background
MAFLD (NAFLD) is considered to be the most common adult chronic liver disease in the world, affecting more than 30% of the world's population. Previous studies have shown that 55%-80% of NAFLD patients have type 2 diabetes. Early assessment and diagnosis of liver steatosis characteristics is crucial for timely treatment or intervention to reduce the risk of liver fibrosis and inhibit disease progression in MAFLD/NAFLD.
At present, liver biopsy is considered as the "gold standard" for evaluating, grading, and determining inflammatory activity of liver steatosis and fibrosis. However, liver biopsy has certain limitations, such as pain, bleeding, infection, bile leakage, leading to the inability to widely use and repeat detection of liver biopsy, especially for dynamic evaluation of patients during treatment .
Therefore, in recent years, non-invasive diagnosis of liver fat content has attracted much attention. Conventional ultrasound is the most commonly used imaging method for evaluating liver steatosis. Conventional abdominal CT can also be used to diagnose fatty liver, but its sensitivity is similar to or even lower than ultrasound, accompanied by radiation, which limits its application in screening and evaluation of fatty liver. Other imaging methods include magnetic resonance spectroscopy (MRS) and magnetic resonance chemical shift coding (MRI) . Magnetic resonance spectroscopy (MRS) uses the difference in resonance frequency between water and fat proton signals to measure proton density fat fraction (PDFF). MRI-PDFF is closely related to histological evaluation of liver fat content and is currently the most sensitive non-invasive method for detecting and quantifying liver steatosis.
UDFF is a novel and unique technology for non-invasive quantification of liver fat content, equipped on the Siemens ACUSON Sequoia ultrasound system. UDFF is calculated from two parameter values: Attenuation Coefficients (AC) and Backscatter Coefficients (BSC). These two parameters are determined by comparing the frequency content of backscattered echo signals at different depths within the tissue and the reference module of the simulated tissue. The AC and BSC values of the reference module are known to be fixed. By comparing, the attenuation of tissues can be separated and their AC can be estimated. The ratio of two spectra and the AC of the module can also be used to estimate the backscatter coefficient of tissue samples. After calculating and estimating the BSC, a unique proprietary mathematical algorithm was used to estimate the UDFF value of the tissue sample at 3MHz. Convert BSC to UDFF in percentage using a special algorithm (P) (linearize the 3MHz BSC to obtain UDFF). Unlike AC and BSC values, the UDFF obtained through special algorithms has a linear relationship with liver fat content. As the fat content level increases, the UDFF index value also increases.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese citizens aged 18 ≤ 85;
- •Routine ultrasound reveals diffuse or non-uniform fatty liver disease in the liver;
- •Conform to the MAFLD diagnostic criteria issued by the international guidelines: histological (liver biopsy), imaging or blood biomarker evidence based on liver fat accumulation (hepatocyte steatosis), and combine one of the following three conditions: overweight/obesity (BMI ≥ 23 kg/m2), type 2 diabetes, and metabolic dysfunction. The definition of metabolic dysfunction is the presence of at least two of the following metabolic risk factors:
- •waist circumference (for Asians) ≥ 90/80 cm (male/female);
- •Arterial blood pressure ≥ 130/85 mmHg is being treated with antihypertensive drugs;
- •Hypertriglyceridemia (TG): fasting serum TG ≥ 150 mg/dl (≥ 1.70 mmol/L) or being treated with lipid-lowering drugs;
- •High density lipoprotein cholesterol (HDL-c) emia: fasting serum HDL-c<40 mg/dl (<1.0 mmol/L) for males,<50 mg/dl (<1.3 mmol/L) for females, or specific medication treatment;
- •Pre diabetes (i.e. fasting blood glucose level 100-125 mg/dl [5.6-6.9 mmol/L], or blood glucose level 140-199 mg/dl [7.8-11.0 mmol] 2 hours after meal or HbA1c 5.7% -6.4% [39-47 mmol/mol]);
- •Steady state model evaluation of insulin resistance score ≥ 2.5;
- •Plasma C-reactive protein levels>2 mg/L.
- •Those who plan to undergo liver histopathological diagnosis or MRI-PDFF assessment of the degree of fatty liver within one week;
- •No significant risk of bleeding (platelet ≥ 50x109/L, international standardized ratio of prothrombin time INR ≤ 1.5);
- •The patient agrees to join this study and signs an informed consent form.
排除标准
- •No histopathological diagnosis or MRI-PDFF was found;
- •The interval between the ultrasound UDFF examination and the histopathological examination or MRI-PDFF examination is more than one week;
- •Incomplete medical history information.
结局指标
主要结局
The combined detection of UDFF and SWE based on ultrasound images
时间窗: 12 months
UDFF technology will be used to detect liver fat content in patients who plan to undergo weight loss surgery, while SWE will be used to monitor liver hardness. Pathological diagnosis will be used as the gold standard to determine the correlation between relevant feature quantities and fibrosis grade, inflammation grade grade, and lipid degeneration grade. Multiple regression equations will be established to form UDFF scores for different degrees of MAFLD and different grading diagnostic thresholds. Analyze its diagnostic effectiveness through internal and external verification methods.
次要结局
未报告次要终点