Non-invasive Evaluation of Liver Fibrosis, Steatosis, and Nonalcoholic Steatohepatitis in Biopsy-Proven NAFLD Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Development of scoring system for diagnosis of NASH
研究概览
简要总结
- To evaluate hepatic fibrosis and steatosis using MR imaging, transient elastography (TE), and serum biomarker
- To develop non-invasive diagnosis marker for NASH and advanced fibrosis
详细描述
As nonalcoholic fatty liver disease (NAFLD) is becoming a leading cause of chronic liver disease, non-invasive diagnosis of disease severity in NAFLD is urgently needed. In this study, the investigators compared hepatic fibrosis and steatosis using MR imaging and transient elastography (TE) and tried to find non-invasive diagnostic marker for NASH and advanced fibrosis.
This is a multicenter prospective study of patients with biopsy-proven NAFLD. The patients were underwent laboratory test, liver biopsy, MRI and TE within 6 months of enrollment. MRI examination included MR spectroscopy (MRS), and MR elastography (MRE). TE measured liver stiffness and controlled attenuation parameter (CAP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >19 years age
- •Patients who had elevated aspartate transaminase(AST)/alanine transaminase(ALT) or fatty liver on abdominal ultrasonography
- •Patients who are clinically suspected to have nonalcoholic steatohepatitis(NASH): >40 years age, BMI >25, multiple features of the metabolic syndrome, presence of diabetes mellitus (DM) , fibroscan > 6 kilopascal (kPa), platelet count < 150,000 /ml, and other patients suspected to progress clinically or requiring diagnosis
- •Patients who underwent (<6 months) or will undergo US-guided liver biopsy
排除标准
- •Chronic liver disease other than nonalcoholic fatty liver disease(NAFLD) (chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis)
- •Excessive alcohol consumption (weekly men >140g and women >70g)
- •Fatty liver due to medication
- •Decompensated liver cirrhosis
- •Contraindication to magnetic resonance imager(MRI)
- •Malignancy or other systemic disease
- •Pregnancy
研究组 & 干预措施
Biopsy proven NAFLD patients
150 subjects who are diagnosed with NAFLD with biopsy from September 2016 to October 2018.
干预措施: Imaging and serologic evaluation of fibrosis and steatosis (Diagnostic Test)
结局指标
主要结局
Development of scoring system for diagnosis of NASH
时间窗: up to 24 months
Development of scoring system for diagnosis of NASH using cox regression analysis
次要结局
- Evaluation of hepatic fibrosis using fibroscan(up to 24 months)
- Evaluation of hepatic steatosis using fibroscan(up to 24 months)
- Evaluation of hepatic fibrosis using serologic marker(up to 24 months)
- Evaluation of hepatic fibrosis using MRI(up to 24 months)
- Evaluation of hepatic steatosis using MRS(up to 24 months)
研究者
Jong Eun Yeon
Professor
Korea University Guro Hospital