Clinical Study of Ultrasound-derived Fat Fraction to Assess Metabolic Dysfunction-Associated Steatotic Liver Disease in Obese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- UDFF values
研究概览
简要总结
Aims: To evaluate the diagnostic performance of ultrasound-derived fat fraction (UDFF) in assessing the degree of hepatic steatosis in an obese population, with liver biopsy as reference standard.
Materials and methods: Obese individuals, who were found to have fatty liver by B-mode ultrasound and underwent UDFF measurement, along with liver biopsy results, were retrospectively selected from The First Affiliated Hospital of Shandong First Medical University.The inclusion criteria were as follows: (1) BMI over 30 kg/m²; (2) diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional B-mode ultrasound; (3) serologic test results were available. The exclusion criteria include: (1) patients who have undergone liver resection or have liver space-occupying lesions; (2) pregnant women; (3) patients with incomplete medical history data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI over 30 kg/m²
- •diffuse fatty liver or inhomogeneous fatty liver diagnosed by conventional B-mode ultrasound
- •serologic test results were available
排除标准
- •patients who have undergone liver resection or have liver space-occupying lesions
- •pregnant women
- •patients with incomplete medical history data
结局指标
主要结局
UDFF values
时间窗: up to 1 year
During the examination, the DAX probe was positioned in the right intercostal space, and the UDFF mode was selected to place a fixed-size region of interest (ROI) vertically in the right lobe of the liver, 1.5 cm away from the liver capsule, avoiding the intrahepatic duct structure. Measurements were acquired after the patient maintained a calm breathing pattern, and the system automatically determined the shear wave velocity (Vs), elastic modulus (E), and UDFF values.
次要结局
- SWE values(up to 1 year)
研究者
Ma Zhe
Director of Ultrasound
Qianfoshan Hospital
