NCT03725631

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

Non-invasive Evaluation of Liver Fibrosis, Steatosis, and Nonalcoholic Steatohepatitis in Biopsy-Proven NAFLD Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Korea University Guro Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Nonalcoholic Fatty Liver
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Imaging 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

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-08-31
• Completion: 2019-08-31
• First posted: 2018-10-31
• Last updated: 2018-10-31

Locations

1 site across 1 country: South Korea