Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
Conditions
Keywords
Magnetic resonance imager(MRI), Nonalcoholic fatty liver disease(NAFLD), Biomarker
Brief summary
1. To evaluate hepatic fibrosis and steatosis using MR imaging, transient elastography (TE), and serum biomarker 2. 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).
Interventions
DIAGNOSTIC_TESTImaging and serologic evaluation of fibrosis and steatosis
Imaging evaluation: Fibroscan, MRI scan for evaluation of fibrosis and steatosis in biopsy proven NAFLD patients Serologic evaluation: serologic test for evaluation of fibrosis and steatosis in biopsy proven NAFLD patients
Sponsors
Korea University Guro Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Development of scoring system for diagnosis of NASH | up to 24 months | Development of scoring system for diagnosis of NASH using cox regression analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of hepatic fibrosis using fibroscan | up to 24 months | Assessment of hepatic fibrosis using fibroscan with transient elastography (kilopascals) (kPa) |
| Evaluation of hepatic steatosis using fibroscan | up to 24 months | Assessment of hepatic steatosis using fibroscan with CAP (Controlled Attenuation Parameter) (dB/m) |
| Evaluation of hepatic fibrosis using MRI | up to 24 months | Assessment of hepatic fibrosis using MRI with MR elastography (MRE) (kPa) |
| Evaluation of hepatic steatosis using MRS | up to 24 months | Assessment of hepatic steatosis using fibroscan with MR spectrography (MRS) (%) |
| Evaluation of hepatic fibrosis using serologic marker | up to 24 months | Assessment of hepatic fibrosis using AST to Platelet Ratio Index (APRI) |
Countries
South Korea
Contacts
Primary ContactJong Eun Yeon, MD, Ph.D.
Backup ContactYoung Sun Lee, MD
Outcome results
None listed