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

Not Applicable

• Conditions: Nonalcoholic Fatty Liver; Nonalcoholic Steatohepatitis
• Interventions: Diagnostic Test: Imaging and serologic evaluation of fibrosis and steatosis

• Registration Number: NCT03725631
• Lead Sponsor: Korea University Guro Hospital

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).

Study Timeline

• Study Start: 2016-09-01
• Study First Submitted: 2018-08-20
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-29
• Last Update Submitted: 2018-10-29
• Study First Posted: 2018-10-31
• Last Update Posted: 2018-10-31
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biopsy proven NAFLD patients	Imaging and serologic evaluation of fibrosis and steatosis	150 subjects who are diagnosed with NAFLD with biopsy from September 2016 to October 2018.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 serologic marker	up to 24 months	Assessment of hepatic fibrosis using AST to Platelet Ratio Index (APRI)
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) (%)

Trial Locations

Locations (1)

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of