Clinical trial NCT03725631: Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD
Official title: Non-invasive Evaluation of Liver Fibrosis, Steatosis, and Nonalcoholic Steatohepatitis in Biopsy-Proven NAFLD Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nonalcoholic Fatty Liver
Nonalcoholic Steatohepatitis
Keywords: Magnetic resonance imager(MRI)
Nonalcoholic fatty liver disease(NAFLD)
Biomarker
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 150
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Development of scoring system for diagnosis of NASH
timeFrame: up to 24 months
Secondary outcomes:
measure: Evaluation of hepatic fibrosis using fibroscan
timeFrame: up to 24 months
measure: Evaluation of hepatic steatosis using fibroscan
timeFrame: up to 24 months
measure: Evaluation of hepatic fibrosis using MRI
timeFrame: up to 24 months
measure: Evaluation of hepatic steatosis using MRS
timeFrame: up to 24 months
measure: Evaluation of hepatic fibrosis using serologic marker
timeFrame: up to 24 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Prefessor
name: Jong Eun Yeon, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
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