RecruitingNCT06707129

Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis


Sponsor

Beijing Municipal Administration of Hospitals

Enrollment

50 participants

Start Date

Aug 1, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

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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.


Locations(1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

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NCT06707129


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