Fatty Liver Disease Collaborative Research in China (FLDCR)

Fatty Liver and Alcoholic Liver Disease Study Group, China

Status: Unknown

Conditions: Fatty Liver; Fatty Liver, Alcoholic; Non-alcoholic Fatty Liver Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02391168

FLD2015

Details and patient eligibility

About

A multi-center, prospective cohort study on the natural history of fatty liver disease in China

Full description

This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with liver biopsy-proven macrovesicular steatosis (>5%) will be enrolled in the baseline cross-sectional analysis. Those who are either diagnosed as NAFLD or ALD, if meeting all the inclusion and exclusion criteria, will be enrolled in the following cohort study, will be followed up after 1 year, 3 years and 5 years with a visit window of +1 month.

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinically diagnosed fatty liver disease, confirmed by liver biopsy.
• Specific biopsy requirements: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
• Only patients with NAFLD or ALD are eligible for the 5-year follow-up cohort study.
• Willing to participate in the long-term follow-up and cooperative.
• Able to provide informed consent file.

Exclusion criteria

• Unable to provide informed consent.

• Patients are eligible for baseline cross-sectional analysis but not eligible for the cohort section, if having any of the following condition:

  1. Any end-stage liver disease.
  2. Any malignant tumor.
  3. Any infection of hepatitis virus or HIV.
  4. Any congenital liver disease such as Wilson disease.
  5. Any other serious disease of projected survival < 5 years.
  6. Combined NAFLD and ALD.