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临床试验/NCT05871749
NCT05871749已完成不适用

Effects of Hepatic Fibrosis on Quantifying Hepatic Steatosis Using the Ultrasound Attenuation Imaging in Patients With Chronic Hepatitis B: a Prospective Study

So Yeon Kim1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年6月7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
Attenuation Coefficient (AC) value at liver parenchyma

研究概览

简要总结

The investigator aimed to prospectively study the effect of the hepatic fibrosis on quantifying hepatic steatosis using ultrasound attenuation imaging (ATI value) in patients with chronic hepatitis B.

详细描述

Chronic hepatitis B virus (HBV) infection has been reported to be associated with the prevalence of non-alcoholic fatty liver disease (NAFLD). Prior studies demonstrate that concurrent fatty liver increases risk of hepatocellular carcinoma among patients with chronic hepatitis B. Therefore, quantification of hepatic steatosis and fibrosis in chronic hepatitis B patient has important clinical significance in active surveillance.

Ultrasound imaging provides reliable noninvasive quantification of hepatic steatosis and fibrosis. Attenuation imaging (ATI) reflects hepatic steatosis and 2D-shear wave elastography reflects hepatic fibrosis.

The potential interaction between of the hepatic fibrosis and the hepatic steatosis in chronic hepatitis B is not fully understood. The investigator investigated the effect of the hepatic fibrosis on quantifying hepatic steatosis using ultrasound attenuation imaging (ATI value) in patients with chronic hepatitis B.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic hepatitis B patients
  • Who is scheduled for pathological exam such as liver biopsy or surgery, that can quantify hepatic steatosis and hepatic fibrosis
  • Who submitted informed consent

排除标准

  • Who underwent liver transplantation or right hemihepatectomy
  • Huge hepatic mass or numerous cysts in right hepatic lobe, who is not eligible for measuring ultrasound attenuation imaging and Fibroscan
  • High bleeding risk patients

结局指标

主要结局

Attenuation Coefficient (AC) value at liver parenchyma

时间窗: During procedure

decibel(dB)/cm/megahertz(MHz)

Pathological hepatic steatosis

时间窗: During procedure

Non-alcoholic Steatohepatitis(NASH) Clinical Research Network scoring system as follows: S0, \<5%; S1, 5%-33%; S2, 34%-66%; S3, ≥67%

Pathological hepatic fibrosis

时间窗: During procedure

Meta-analysis of histological data in viral hepatitis(METAVIR) scoring system as follows: F0, no fibrosis; F1, portal fibrosis without septa; F2, portal fibrosis with rare septa; F3, numerous septa without cirrhosis; and F4, cirrhosis

次要结局

未报告次要终点

研究者

发起方
So Yeon Kim
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

So Yeon Kim

Clinical Professor

Asan Medical Center

研究点 (1)

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