Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

NCT06707129 | Recruiting

• 1 other identifier: ZLRK202301
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

non-alcoholic fatty liver disease; nonalcoholic steatohepatitis; liver biopsy; Fibrosis reversal; histopathology

Outcome Measures

Primary Outcomes (1)

• Reversal of NASH liver fibrosis

  Reversal of NASH liver fibrosis based on liver biopsy definition

  12 months

Secondary Outcomes (18)

• Changes in LSM value

  12 months

• Changes in liver fat content

  12 months

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

  12 months

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

  12 months

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

  12 months

Study Arms (1)

Case group

After successful patient screening and enrollment, visits will be conducted every 6 months to collect the following information: Physical examination, accompanying diseases, hematology: blood routine, coagulation function, serology, imaging, body fat measurement, liver puncture information (if applicable). Lifestyle questionnaire: Dietary characteristics, sleep/wake time, daily sitting time, exercise duration, exercise mode. Health education and lifestyle intervention guidance should be provided to patients based on exercise mode. When adjusting lifestyle for at least 1 year and no more than 3 years, a second liver biopsy should be performed to evaluate liver histological changes.

Other: life-style

Interventions

life-style OTHER

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.

Case group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Municipal Administration of Hospitals: lead

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Central Study Contacts

Minghui Li

CONTACT

+8613693259096; wuhm2000@sina.com

Weihua Cao

CONTACT

+8618811333129; weihuacaohappy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Professor of Hepatology Department 2

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 27, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

CN (1)