Diagnostic accuracy of novel scoring systems using serum biomarkers for nonalcoholic steatohepatitis (NASH) - Diagnosis of nonalcoholic steatohepatitis by serum biomarkers

Saiseikai Suita Hospital0 sites400 target enrollmentJuly 2, 2015

Conditionsonalcoholic fatty liver disease (NAFLD)

Overview

Phase: 未知
Intervention: Not specified
Conditions: onalcoholic fatty liver disease (NAFLD)
Sponsor: Saiseikai Suita Hospital
Enrollment: 400
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 2, 2015

End Date

November 10, 2016

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Saiseikai Suita Hospital

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•1\) Patients whose alcohol consumption in the preceding year of the liver biopsy were more than 210g/week (30g/day) for men or 140g/week (20g/day) for women (at the time of liver biopsy and blood sampling) 2\) Patients who have the following result(s) of immunological test (at the time of liver biopsy and blood sampling) \-Hepatitis B (HBs antigen \>\=0\.05U/ml) \-Hepatitis C (HCV RNA positive) \-Patients who are autoimmune hepatitis (titer of antinuclear antibodies is equal to or more than 80 fold and IgG is equal to or more than 2g/dL, or autoimmune hepatitis diagnosed by histopathology) \-Patients who are primary biliary cirrhosis 3\) Patients who are suspected another chronic liver disease (at the time of liver biopsy and blood sampling) (e.g., primary sclerosing cholangitis, hemochromatosis, alpha1\-antitrypsin deficiency, Wilson's disease, drug\-induced hepatic impairment (including fatty liver induced by adrenocortical steroid)) 4\) Patients who have history of hepatic, biliary or pancreatic malignant tumor 5\) Patients who have liver decompensation such as hepatic encephalopathy, abdominal dropsy,jaundice, variceal hemorrhage, serum bilirubin level more than 2 times of the upper limit of normal (at the time of liver biopsy and blood sampling) 6\) Patients whose preserved serum sample repeated freeze\-thaw cycles more than six times 7\) Patients whose preserved serum sample(s) and/or liver specimen are unsuitable for the diagnosis of NASH in the opinion of the investigator. 8\) In the opinion of the investigator, patient are unsuitable as a study subject