Non-alcoholic Fatty Liver Disease
Conditions
Keywords
non-alcoholic fatty liver disease, nonalcoholic steatohepatitis, liver biopsy, Fibrosis reversal, histopathology
Brief summary
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.
Detailed description
Confirmed NAFLD patients were enrolled, and those with NASH and fibrosis F2-4 stages confirmed by liver biopsy were selected, and clinical and pathological data were collected for relevant evaluation and definition. A NASH fibrosis reversal pathological evaluation system was established based on the new standard, and an alternative non-invasive indicator and observation index were established based on the reversal standard.
Interventions
OTHERlife-style
The 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.
Sponsors
Beijing Municipal Administration of Hospitals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reversal of NASH liver fibrosis | 12 months | Reversal of NASH liver fibrosis based on liver biopsy definition |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in liver fat content | 12 months | Instantaneous liver elasticity detection of changes in liver fat content (CAP value) |
| The dynamic changes of existing non-invasive evaluation models for fibrosis | 12 months | The dynamic changes of existing non-invasive evaluation models for fibrosis include: APRI=AST(ULN)/PLT(10\^9/L)×100 |
| Dynamic changes in metabolic indicators of NAFLD | 12 months | Dynamic changes in metabolic indicators of NAFLD, including BMI; |
| Changes in LSM value | 12 months | Changes in liver stiffness value (LSM value) detected by instantaneous liver elasticity testing |
| The occurrence of liver outcome events | 12 months | The occurrence of liver outcome events: decompensation of cirrhosis (ascites, rupture of esophageal and gastric varices) Blood, hepatic encephalopathy, hepatocellular carcinoma, liver related deaths/liver transplantation. |
| Extrahepatic related events | 12 months | Extrahepatic related events: cardiovascular and cerebrovascular events, extrahepatic malignant tumors, and newly developed metabolic diseases. |
| The occurrence of cirrhosis | 12 months | The occurrence of cirrhosis: that is, when the liver biopsy did not indicate cirrhosis at the time of enrollment, cirrhosis occurred during follow-up. |
Countries
China
Contacts
Primary ContactMinghui Li
Backup ContactWeihua Cao
Outcome results
None listed