Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Beijing Municipal Administration of Hospitals50 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

life-styleOTHER

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Reversal of NASH liver fibrosis

Reversal of NASH liver fibrosis based on liver biopsy definition

Time frame: 12 months

Secondary Outcomes

Changes in LSM value

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

Time frame: 12 months

Changes in liver fat content

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

Time frame: 12 months

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

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

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

The dynamic changes of existing non-invasive evaluation models for fibrosis include: BARD：BMI ≥28, AST/ALT ≥0.8, diabetes

Time frame: 12 months

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

The dynamic changes of existing non-invasive evaluation models for fibrosis include: NAFLD Fibrosis Score

Time frame: 12 months

Central Contacts

Minghui Li

CONTACT

+8613693259096 wuhm2000@sina.com

Weihua Cao

CONTACT

+8618811333129 weihuacaohappy@163.com

Data from ClinicalTrials.gov

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