Non-invasive Diagnostic Model of Liver Fibrosis Associated With NAFLD and Prediction of Prognosis

NCT03842748 | Unknown

• 1 other identifier: XXZ0302
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

In a retrospective study, 200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fatty liver fibrosis have been identified for pathological diagnosis of liver histology and exclusion of other liver diseases. Before the liver biopsy were performed, these patients should detect liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity measurement and imaging indicators and results, and demographic data. To evaluate the diagnostic ability of the current non-invasive diagnostic model of NAFLD fibrosis and the adaptability of model indicators to the diagnosis of enrolled patients, and to correct the indicators, including discarding unsuitable indicators and incorporating new indicators, and adjusting the diagnostic score. Establish a non-invasive diagnostic model for liver fibrosis in Beijing based on NAFLD. In a prospective observational study, 100 patients without other liver diseases and ultrasound-tested fatty liver were enrolled, and histopathological diagnosis of liver were included in the study, and liver function, coagulation function, renal function, blood glucose, and non-invasive model analysis were detected. Blood lipids, liver elasticity measurements, and imaging indicators were examined and demographic data were collected. The non-invasive diagnostic model established by retrospective study was used to diagnose fibrosis and its staging, compared with histopathological diagnosis, and adjusted the index of non-invasive diagnostic model to further revise and improve the diagnostic efficacy of the diagnostic model. Long-term follow-up observations were performed in the prospective observation cohort. The liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity and imaging examination were performed during the observation period, and the treatment events and the progress of the patients were recorded. To explore the correlation and predictive ability of noninvasive diagnostic models for long-term outcomes of disease. Finally, a model for predicting the outcome of progression of liver fibrosis in NAFLD was established.

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Nonalcoholic; fatty liver; hepatitis; liver fibrosis

Outcome Measures

Primary Outcomes (1)

• Correlation between clinical biochemical parameters of nonalcoholic fatty liver disease and pathological diagnosis of liver perforation

  Correlation between clinical biochemical parameters of nonalcoholic fatty liver disease and pathological diagnosis of liver perforation, and the change of clinical biochemical parameters of nonalcoholic fatty liver disease

  at baseline, 24weeks, 48weeks, 72weeks, 96weeks, 120weeks, 144weeks, 168weeks, 192weeks.

Study Arms (2)

Retrospective study group

200 patients with non-alcoholic fatty liver disease, fatty liver hepatitis, and fibrosis have been identified for pathological diagnosis of liver histology and without other liver diseases. Before liver biopsy were performed, liver function, coagulation function, renal function, blood glucose, blood lipids, liver elasticity measurement, imaging indicators and demographic data were detected and recorded. To evaluate diagnostic ability of current non-invasive diagnostic model of NAFLD fibrosis and adaptability of model indicators to diagnosis of these patients, and correct the indicators including discarding unsuitable and incorporating new indicators and adjusting the diagnostic score. Establish a non-invasive diagnostic model for liver fibrosis in Beijing based on NAFLD.

Prospective observational study group

100 patients without other liver diseases and ultrasound-tested fatty liver were enrolled, and histopathological diagnosis of liver were included , and liver function, coagulation function, renal function, blood glucose, and non-invasive model analysis, blood lipids, liver elasticity measurements and imaging indicators were examined and demographic data were collected. Adjusted the index of non-invasive diagnostic model to further revise and improve the diagnostic efficacy of diagnostic model. Long-term follow-up observations were performed in the prospective observation cohort. To explore the correlation and predictive ability of noninvasive diagnostic models for long-term outcomes of disease. Finally, a model for predicting the outcome of progression of liver fibrosis in NAFLD was established.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject of this study was patients with non-alcoholic fatty liver, fatty liver hepatitis and fatty liver fibrosis diagnosed by histopathology of the liver. Patients enrolled in the study excluded other liver diseases such as alcoholic fatty liver and hepatitis, viral hepatitis. , autoimmune diseases, drug-induced hepatitis and liver cancer.

You may qualify if:

• patients with non-alcoholic fatty liver, fatty liver hepatitis and fatty liver fibrosis: all meet the diagnostic criteria of China's "Guidelines for the Prevention and Treatment of Non-alcoholic Fatty Liver Diseases (2018 Update)";
• Age between 18 and over 75;
• patient were never treated with no hormones and / or immunosuppressants and other liver protection drugs.

You may not qualify if:

• combined with hepatitis virus infection;
• autoimmune liver disease;
• HIV infection;
• long-term alcohol abuse and / or other liver damage drugs;
• mental illness;
• Evidence of liver tumors (liver cancer or AFP \> 100 ng/ml);
• decompensated cirrhosis;
• Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up.

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; Fatty Liver; Hepatitis; Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Minghui Li, master

  Liver Diseases Center, Beijing Ditan Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minghui Li, master

CONTACT

8613693259096; wuhm2000@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 192 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Liver Diseases Center

Study Record Dates

• First Submitted: January 19, 2019
• First Posted: February 15, 2019
• Study Start: January 1, 2018
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2021
• Last Updated: February 15, 2019

Record last verified: 2019-02

Locations

CN (1)