Nonalcoholic fatty liver disease NAFLD, NAFLD/NASH, liver biopsy, MRE, ultrasound elastography
Conditions
Interventions
Using the results of liver fibrosis by liver biopsy as the gold standard, we will evaluate the superiority of specificity (the probability of judging a patient with F2 or lower as negative) for the di
Sponsors
Nogami Asako
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients clinically diagnosed with non-alcoholic fatty liver disease and scheduled for liver biopsy 2) A patient with a malignant disease other than hepatocellular carcinoma who is currently undergoing treatment. 3) With or without hepatocellular carcinoma complications at the time of enrollment 4) Patients with a PS (ECOG performance status) of 2 or less and able to attend the outpatient clinic within 12 weeks of liver biopsy 5) Patients who have obtained written consent from the patient to participate in the study, who have complied with the requirements during their participation in the study, who have been examined as specified in the study protocol, and who are able to report their symptoms, etc. 6) Have participated in another clinical trial (including a clinical trial) prior to enrollment or are currently participating in another clinical trial, but would have no problem adding this study to the clinical trial in which they are participating.
Exclusion criteria
Exclusion criteria: (1) Patients with liver disease other than nonalcoholic fatty liver disease 2) Patients with malignant diseases other than hepatocellular carcinoma (however, patients who have undergone radical surgery or completed administration of anticancer drugs can be enrolled, but patients under observation and evaluation for malignancy are excluded) 3) Serious complications (liver disease: Child-Pugh classification C or higher, kidney disease: cardiac disease: NYHA classification III or higher) 4) Patients with serious mental illness (5) patients who have been abusing alcohol and drugs (6) Patients who are pregnant, lactating, may be pregnant, or wish to become pregnant (7) Patients for whom a liver biopsy is contraindicated (bleeding tendency, ascites) (8) Other patients who are deemed by the principal investigator (or sub-doctor) to be unsuitable as subjects
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Specificity for diagnosis of advanced fibrosis by ultrasonic elastography performed once and twice | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of sensitivity in the diagnosis of advanced fibrosis compared to single ultrasound elastography Positive predictive value for the diagnosis of advanced fibrosis compared to a single ultrasound elastography Negative predictive value for the diagnosis of advanced fibrosis compared to a single ultrasound elastography | — |
Contacts
Public ContactAsako Nogami
Yokohama City University Hospital
Outcome results
None listed