Establishment of Precise Histological Evaluation Criteria for Reversal of NASH Fibrosis
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Beijing Ditan Hospital, Capital Medical University
RECRUITING
Beijing
Contact Information
Primary
Minghui Li
wuhm2000@sina.com
+8613693259096
Backup
Weihua Cao
weihuacaohappy@163.com
+8618811333129
Time Frame
Start Date: 2024-08-01
Estimated Completion Date: 2027-08-31
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Beijing Municipal Administration of Hospitals