Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-70
SponsorBeijing Municipal Administration of Hospitals

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Patients diagnosed with NAFLD were enrolled, and patients with NASH and fibrosis stage F2-4 confirmed by liver biopsy were screened

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • life-style

    Other intervention

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Case group1 intervention

Trial outcomes

Primary outcomes

1

Reversal of NASH liver fibrosis

Reversal of NASH liver fibrosis based on liver biopsy definition

Time frame
12 months

Secondary outcomes

1

Changes in LSM value

Changes in liver stiffness value (LSM value) detected by instantaneous liver elasticity testing

Time frame
12 months
2

Changes in liver fat content

Instantaneous liver elasticity detection of changes in liver fat content (CAP value)

Time frame
12 months
3

The dynamic changes of existing non-invasive evaluation models for fibrosis

The dynamic changes of existing non-invasive evaluation models for fibrosis include: APRI=AST(ULN)/PLT(10\^9/L)×100

Time frame
12 months
4

The dynamic changes of existing non-invasive evaluation models for fibrosis

The dynamic changes of existing non-invasive evaluation models for fibrosis include: FIB-4: Age, AST, ALT, platelets

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Municipal Administration of Hospitals

Lead sponsor

Beijing Ditan Hospital

Sponsor institution