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Recruiting NCT06707129

Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

— Observational Non-alcoholic Fatty Liver Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: life-style.
Who it may be relevant to
Registry conditions: Non-alcoholic Fatty Liver Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis

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.

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

  • Other life-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.

Primary outcome measures

  • Reversal of NASH liver fibrosis [Time frame: 12 months]
Secondary outcome measures (12)
  • Changes in LSM value [Time frame: 12 months]
  • Changes in liver fat content [Time frame: 12 months]
  • The dynamic changes of existing non-invasive evaluation models for fibrosis [Time frame: 12 months]
  • The dynamic changes of existing non-invasive evaluation models for fibrosis [Time frame: 12 months]
  • The dynamic changes of existing non-invasive evaluation models for fibrosis [Time frame: 12 months]
  • The dynamic changes of existing non-invasive evaluation models for fibrosis [Time frame: 12 months]
  • The dynamic changes of existing non-invasive evaluation models for fibrosis [Time frame: 12 months]
  • Dynamic changes in metabolic indicators of NAFLD [Time frame: 12 months]
  • Dynamic changes in metabolic indicators of NAFLD [Time frame: 12 months]
  • Dynamic changes in metabolic indicators of NAFLD [Time frame: 12 months]
  • Dynamic changes in metabolic indicators of NAFLD [Time frame: 12 months]
  • Dynamic changes in metabolic indicators of NAFLD [Time frame: 12 months]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Beijing Ditan Hospital, Capital Medical University — Beijing

Identifiers

NCT: NCT06707129 · ZLRK202301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗