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

Non-alcoholic Fatty Liver Disease Clinical Trial

Official title:

Non-invasive Diagnostic Model of Liver Fibrosis Associated With Non-alcoholic Fatty Liver Disease and Prediction of Prognosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842748
• Other study ID #: XXZ0302
• Status: Recruiting
• Start date: January 1, 2018
• Est. completion date: December 30, 2021

Study information

• Verified date: February 2019
• Source: Beijing Municipal Administration of Hospitals
• Contact: Minghui Li, master
• Phone: 8613693259096
• Email: wuhm2000[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

This topic is a prospective - retrospective observational study including two parts, retrospective and prospective: 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. The liver biopsy performed in the enrolled patients included 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 included. 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 improve and improve the diagnostic efficacy of the diagnostic model. Long-term follow-up observations were performed on 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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)";

2. Age between 18 and over 75;

3. patient were never treated with no hormones and / or immunosuppressants and other liver protection drugs.

Exclusion Criteria:

1. combined with hepatitis virus infection;

2. autoimmune liver disease;

3. HIV infection;

4. long-term alcohol abuse and / or other liver damage drugs;

5. mental illness;

6. Evidence of liver tumors (liver cancer or AFP > 100 ng/ml);

7. decompensated cirrhosis;

8. Serious diseases such as heart, brain, lung, kidney, etc. can not participate in long-term follow-up.

Related Conditions & MeSH terms

• Fatty Liver
• Fibrosis
• Liver Cirrhosis
• Liver Diseases
• Non-alcoholic Fatty Liver Disease

Locations

Country	Name	City	State
China	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Municipal Administration of Hospitals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.