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临床试验/NCT06487325
NCT06487325已完成不适用

Clinical Study of Ultrasound-derived Fat Fraction to Assess Metabolic Dysfunction-Associated Steatotic Liver Disease in Obese Population

Ma Zhe1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年4月29日最近更新:
适应症

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

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

发起方
Ma Zhe
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ma Zhe

Director of Ultrasound

Qianfoshan Hospital

研究点 (1)

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