Establishment of NAFLD Cohort and Development of Fibrosis Markers

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSeoul National University Boramae Hospital

About this trial

This study is designed for establishment of non-alcoholic fatty liver disease patients cohort to development of markers to predict histologic progression of liver fibrosis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with histologically confirmed fatty liver disease

Patients with radiologically confirmed fatty liver disease

Disqualifiers

History of significant alcohol consumption

Viral hepatitis

Autoimmune hepatitis

Metabolic diseases (e.g. hemochromatosis, M. Wilson, alpha 1-antitrypsin deficiency)

Trial population

Non-alcoholic fatty liver disease

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Liver biopsy

    Procedure/Surgery

    Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis.

  • ARFI

    Device

    Acoustic radiation force impulse (ARFI) imaging will be performed for evaluate fibrosis of liver.

  • SWE

    Device

    Supersonic shear wave elastography (SWE) will be performed for evaluate fibrosis of liver.

  • Transient elastography

    Device

    Transient elastography will be performed for evaluate fibrosis of liver.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: NAFLD4 interventions

Trial outcomes

Primary outcomes

1

histologic steatosis and fibrosis grade

We will evaluate fibrosis using laboratory examination, radiologic evaluation and liver tissue pathology.

Time frame
baseline

Secondary outcomes

1

Development of markers for hepatic fibrosis progression

We will analysis and development fibrosis markers by obtained blood sample and liver tissue,

Time frame
baseline and every 6 months (up to 1year)

Other outcomes

Sponsors and contacts

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