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临床试验/NCT03842748
NCT03842748Unknown不适用

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

Beijing Municipal Administration of Hospitals1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
1
主要终点
Correlation between clinical biochemical parameters of nonalcoholic fatty liver disease and pathological diagnosis of liver perforation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

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

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

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

次要结局

未报告次要终点

研究者

发起方
Beijing Municipal Administration of Hospitals
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Minghui Li

Head of Liver Diseases Center

Beijing Ditan Hospital

研究点 (1)

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