Clinical trial NCT06707129: Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal
Official title: Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: non-alcoholic fatty liver disease
nonalcoholic steatohepatitis
liver biopsy
Fibrosis reversal
histopathology
Lead sponsor: Beijing Municipal Administration of Hospitals
Sponsor class: OTHER_GOV
First posted: 2024-11-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with NAFLD were enrolled, and patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy were screened

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reversal of NASH liver fibrosis
timeFrame: 12 months
Secondary outcomes:
measure: Changes in LSM value
timeFrame: 12 months
measure: Changes in liver fat content
timeFrame: 12 months
measure: The dynamic changes of existing non-invasive evaluation models for fibrosis
timeFrame: 12 months
measure: The dynamic changes of existing non-invasive evaluation models for fibrosis
timeFrame: 12 months
measure: The dynamic changes of existing non-invasive evaluation models for fibrosis
timeFrame: 12 months
measure: The dynamic changes of existing non-invasive evaluation models for fibrosis
timeFrame: 12 months
measure: The dynamic changes of existing non-invasive evaluation models for fibrosis
timeFrame: 12 months
measure: Dynamic changes in metabolic indicators of NAFLD
timeFrame: 12 months
measure: Dynamic changes in metabolic indicators of NAFLD
timeFrame: 12 months
measure: Dynamic changes in metabolic indicators of NAFLD
timeFrame: 12 months
measure: Dynamic changes in metabolic indicators of NAFLD
timeFrame: 12 months
measure: Dynamic changes in metabolic indicators of NAFLD
timeFrame: 12 months
measure: Dynamic changes in metabolic indicators of NAFLD
timeFrame: 12 months
measure: Dynamic changes in metabolic indicators of NAFLD
timeFrame: 12 months
measure: Dynamic changes in metabolic indicators of NAFLD
timeFrame: 12 months
measure: The occurrence of cirrhosis
timeFrame: 12 months
measure: The occurrence of liver outcome events
timeFrame: 12 months
measure: Extrahepatic related events
timeFrame: 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital, Capital Medical University
state: Beijing
Study officials:
References: