A Study of the Usefulness of Two Ultrasound Elastographies in NAFLD
- Conditions
- onalcoholic fatty liver diseaseNAFLD, NAFLD/NASH, liver biopsy, MRE, ultrasound elastography
- Registration Number
- JPRN-jRCTs032200447
- Lead Sponsor
- ogami Asako
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 52
1) Patients clinically diagnosed with non-alcoholic fatty liver disease and scheduled for liver biopsy
2) Patients who are at least 20 years old at the time of obtaining the consent form, regardless of gender
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 after 3 week 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.
(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: CKD stage 4 or higher, 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method