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Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Recruiting
18-70 years
All
Phase N/A

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Overview

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.

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

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.

Study details
    Non-alcoholic Fatty Liver Disease

NCT06707129

Beijing Municipal Administration of Hospitals

16 October 2025

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