Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

Recruiting

• Conditions: Non-alcoholic Fatty Liver Disease

• Registration Number: NCT06707129
• Lead Sponsor: Beijing Municipal Administration of Hospitals

Brief 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.

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.

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-19
• Study First Submitted QC: 2024-11-23
• Last Update Submitted: 2024-11-23
• Study First Posted: 2024-11-27
• Last Update Posted: 2024-11-27
• Primary Completion: 2027-08-31
• Study Completion: 2027-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reversal of NASH liver fibrosis	12 months	Reversal of NASH liver fibrosis based on liver biopsy definition

Secondary Outcome Measures

Name	Time	Method
Changes in LSM value	12 months	Changes in liver stiffness value (LSM value) detected by instantaneous liver elasticity testing
Changes in liver fat content	12 months	Instantaneous liver elasticity detection of changes in liver fat content (CAP value)
The dynamic changes of existing non-invasive evaluation models for fibrosis	12 months	The dynamic changes of existing non-invasive evaluation models for fibrosis include: FAST
Dynamic changes in metabolic indicators of NAFLD	12 months	Dynamic changes in metabolic indicators of NAFLD, including blood lipid series;
The occurrence of cirrhosis	12 months	The occurrence of cirrhosis: that is, when the liver biopsy did not indicate cirrhosis at the time of enrollment, cirrhosis occurred during follow-up.
The occurrence of liver outcome events	12 months	The occurrence of liver outcome events: decompensation of cirrhosis (ascites, rupture of esophageal and gastric varices) Blood, hepatic encephalopathy, hepatocellular carcinoma, liver related deaths/liver transplantation.
Extrahepatic related events	12 months	Extrahepatic related events: cardiovascular and cerebrovascular events, extrahepatic malignant tumors, and newly developed metabolic diseases.

Trial Locations

Locations (1)

Beijing Ditan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China