Non-invasive Evaluation of Liver Fibrosis, Steatosis, and NASH in NAFLD

Korea University

Status: Unknown

Conditions: Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis

Treatments: Diagnostic Test: Imaging and serologic evaluation of fibrosis and steatosis

Study type: Interventional

Funder types: Other

Identifiers

NCT03725631

2016GR0302

Details and patient eligibility

About

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

Full 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).

Enrollment: 150 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Biopsy proven NAFLD patients

Experimental group

Description:

150 subjects who are diagnosed with NAFLD with biopsy from September 2016 to October 2018.

Treatment:

Diagnostic Test: Imaging and serologic evaluation of fibrosis and steatosis