Non-invasive Evaluation of Liver Fibrosis, Steatosis, and Nonalcoholic Steatohepatitis in Biopsy-Proven NAFLD Patients
Overview
- Phase
- Not Applicable
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Development of scoring system for diagnosis of NASH
Overview
Brief Summary
- 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
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Development of scoring system for diagnosis of NASH
Time Frame: up to 24 months
Development of scoring system for diagnosis of NASH using cox regression analysis
Secondary Outcomes
- 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)
Investigators
Jong Eun Yeon
Professor
Korea University Guro Hospital