Real World Study of End-stage Liver Disease in China

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.

Study Overview

• Status: Recruiting
• Conditions: Complication; End Stage Liver DIsease
• Intervention / Treatment: Other: No intervation

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 10000

Contacts and Locations

• Study Contact: Name: Jingwen Ai, Doctor; Phone Number: 02152887969 13764990804; Email: JINGWENAI1990@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital
      • Contact: Jingwen Ai, Doctor; Phone Number: 02152887969 13764990804; Email: JINGWENAI1990@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The population who were diagnosed of acute decompensation of cirrhosis, chronic and acute liver failure, chronic liver failure or hepatocellular carcinoma (stage III-IV)

Description

Inclusion Criteria:

1. Informed consent of patients.
2. 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)

Exclusion Criteria:

1. HIV antibody positive and AIDS patients
2. 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.
3. Patients with serious diseases of heart, lung, kidney, brain, blood and other important organs.
4. Patients with other malignant tumors (excluding those cured).
5. Pregnant, lactating women or women of childbearing age who are ready to conceive.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient died during follow-up	Death occurred during 3 year	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major events occurred during follow-up	the major events including liver transplantation and the happening of serious complications	3 years

Collaborators and Investigators

• Sponsor: Huashan Hospital

Publications and helpful links

General Publications

• GBD 2016 Causes of Death Collaborators. Global, regional, and national age-sex specific mortality for 264 causes of death, 1980-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017 Sep 16;390(10100):1151-1210. doi: 10.1016/S0140-6736(17)32152-9. Erratum In: Lancet. 2017 Oct 28;390(10106):e38.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): September 1, 2029

Study Registration Dates

• First Submitted: July 14, 2019
• First Submitted That Met QC Criteria: July 29, 2019
• First Posted (Actual): July 30, 2019

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Failure; Hepatic Insufficiency; Liver Diseases; End Stage Liver Disease
• Other Study ID Numbers: KY2019-RWS(LD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No