跳至主要内容
临床试验/NCT04037995
NCT04037995招募中不适用

Real World Study of End-stage Liver Disease in China

Huashan Hospital1 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
10,000
试验地点
1
主要终点
Patient died during follow-up

研究概览

简要总结

The aims of this study are exploring the current situation of end-stage liver disease in China, and the optimization of diagnosis and treatment. Liver cirrhosis often accompanied by a series of complications. Therefore, it is necessary to standardize the diagnosis and treatment of liver cirrhosis and its complications. End-stage liver disease mainly refers to the late stage of liver disease caused by various chronic liver damage. Its main feature is that liver function can not meet the physiological needs of human body. This study is a single-center, prospective and observational real-world study aimed at investigating and analyzing the current diagnosis and treatment of liver cirrhosis and end-stage liver disease in China.

详细描述

The aims of this study are exploring the current situation of end-stage liver disease in China, and the optimization of diagnosis and treatment. Liver cirrhosis includes cirrhosis caused by hepatitis, alcoholic cirrhosis, non-alcoholic cirrhosis and schistosomiasis cirrhosis. Liver cirrhosis often accompanied by a series of complications, including portal hypertension and gastrointestinal bleeding, ascites and related infections, hepatorenal syndrome, hepatic encephalopathy, portal vein thrombosis, etc. Therefore, it is necessary to standardize the diagnosis and treatment of liver cirrhosis and its complications, but there are still disputes about most of the complications in various editions of the guidelines. In order to formulate the best empirical treatment plan, it is indispensable to master the epidemiological situation of cirrhosis in different places. However, there is a lack of support from large clinical data from China. End-stage liver disease mainly refers to the late stage of liver disease caused by various chronic liver damage. Its main feature is that liver function can not meet the physiological needs of human body. It covers the final stages of various chronic liver diseases, mainly manifested as severe impairment and decompensation of liver function, including chronic and acute liver failure, acute decompensation of cirrhosis, chronic liver failure and hepatocellular carcinoma. The concept of end-stage liver disease was first put forward in the 1980s and has not been strictly defined yet. However, due to the complications of end-stage liver disease, such as infection related to liver failure and portal hypertension, septic shock, hepatic encephalopathy, and serious decline in quality of life, and the one-year survival rate of most patients is less than 90%, it is necessary to put forward this concept. Therefore, there is still a need for large sample data to define end-stage liver disease and formulate evidence-based treatment plans.

The aim of this study is to explore the efficacy, safety and economic benefits of different treatment options for patients with cirrhosis and complications and end-stage liver disease in the real world of China. To investigate the epidemiological rates of cirrhosis and end-stage liver disease, and to provide evidence-based medical evidence for the treatment and follow-up of cirrhosis and end-stage liver disease in China in the future.

This study is a single-center, prospective and observational real-world study aimed at investigating and analyzing the current diagnosis and treatment of end-stage liver disease in China, exploring the situation of end-stage liver disease in China, exploring the treatment options for patients with end-stage liver disease that can effectively improve their prognosis, and seeking high-quality evidence-based medical treatment for cirrhosis and reducing the mortality of end-stage liver disease.

研究设计

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

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

  • Informed consent of patients.
  • Diagnosis of any of the following diseases: acute decompensation of cirrhosis, chronic and acute liver failure, chronic liver failure and hepatocellular carcinoma (stage III-IV)

排除标准

  • HIV antibody positive and AIDS patients
  • Serious psychiatric history, especially depression. Severe mental illness is defined as major depression or psychosis, suicide attempts, hospitalization due to mental illness or a period of disability due to mental illness.
  • Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.
  • Patients with other malignant tumors (excluding those cured).
  • Pregnant, lactating women or women of childbearing age who are ready to conceive.

结局指标

主要结局

Patient died during follow-up

时间窗: 3 years

Death occurred during 3 year

次要结局

  • Major events occurred during follow-up(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wen-hong Zhang

Chief of dpartment of infectious disease

Huashan Hospital

研究点 (1)

Loading locations...

相似试验

Real World Study of End-stage Liver Disease in China | 临床试验