About this trial
Collect confirmed cases of NAFLD patients and enroll them in the study. Select patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy, and collect clinical and pathological data for relevant evaluation and definition. Establish a NASH "fibrosis reversal" pathological evaluation system, based on a new reversal standard, establish non-invasive alternative indicators, and observe indicators.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged between 18 and 70 years at the time of liver biopsy;
Gender is not limited;
Hepatic perforation suggested that NASH complicated with fibrosis stage F2-4;
Signed written informed consent.
Disqualifiers
Combined HCV infection, HIV infection, alcoholic liver disease, autoimmune liver disease, genetic metabolic liver disease Disease, drug-induced liver injury and other chronic liver diseases;
Women during pregnancy;
There are the following conditions before liver perforation: HCC or possible HCC (imaging suggests malignant liver occupation); decompensation of cirrhosis (ascites, hepatic encephalopathy, gastrointestinal bleeding, hepatorenal syndrome, etc.); Patients with other malignant tumors; Recipients of liver transplantation;
Patients considered by the investigator to be unsuitable for this study.
Trial population
Patients diagnosed with NAFLD were enrolled, and patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy were screened
Trial design
Cohort
Prospective
Treatments tested in this trial
life-style
Other interventionThe patients were given health education and lifestyle intervention guidance, followed by lifestyle adjustment for at least 1 year and no more than 3 years, and a second liver biopsy was performed to evaluate liver histological changes.
Treatment groups
Trial outcomes
Primary outcomes
Reversal of NASH liver fibrosis
Reversal of NASH liver fibrosis based on liver biopsy definition
Secondary outcomes
Changes in LSM value
Changes in liver stiffness value (LSM value) detected by instantaneous liver elasticity testing
Changes in liver fat content
Instantaneous liver elasticity detection of changes in liver fat content (CAP value)
The dynamic changes of existing non-invasive evaluation models for fibrosis
The dynamic changes of existing non-invasive evaluation models for fibrosis include: APRI=AST(ULN)/PLT(10\^9/L)×100
The dynamic changes of existing non-invasive evaluation models for fibrosis
The dynamic changes of existing non-invasive evaluation models for fibrosis include: FIB-4: Age, AST, ALT, platelets
Sponsors and contacts
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Beijing Municipal Administration of Hospitals
Lead sponsor
Beijing Ditan Hospital
Sponsor institution