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Establishment of Precise Histological Evaluation Criteria for NASH Fibrosis Reversal

NCT ID: NCT06707129

Last Updated: 2024-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2027-08-31

Brief Summary

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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

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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.

Conditions

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Non-alcoholic Fatty Liver Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

life-style

Intervention Type 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.

Interventions

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life-style

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Municipal Administration of Hospitals

OTHER_GOV

Sponsor Role lead

Responsible Party

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Minghui Li

Director and Professor of Hepatology Department 2

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Minghui Li

Role: CONTACT

[email protected]
+8613693259096

Weihua Cao

Role: CONTACT

[email protected]
+8618811333129

Facility Contacts

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Minghui Li, Dr

Role: primary

[email protected]
+8613693259096

Weihua Cao, Dr

Role: backup

[email protected]
+8618811333139

Other Identifiers

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ZLRK202301

Identifier Type: -

Identifier Source: org_study_id