End Stage Liver DIseaseNCT04037995
Real World Study of End-stage Liver Disease in China
An observational study of End Stage Liver DIsease and Complication, run by Huashan Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- End Stage Liver DIsease, Complication
- What is being tested?
- No intervation
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 1 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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)
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
HuaShan Hospital
Shanghai, Shanghai Municipality, 200040
Jingwen Ai, Doctor, 13764990804 ext. 02152887969, JINGWENAI1990@126.com
About this study
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.
Read the 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.
- Conditions
- End Stage Liver DIsease, Complication
- Being tested
- No intervation
- Medical subject headings
- End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervationOther
No intervation
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient died during follow-up
Death occurred during 3 year
Measured: 3 years
Secondary outcomes (1)
Major events occurred during follow-up
the major events including liver transplantation and the happening of serious complications
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2020 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Liver DIseaseStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-hong Zhang, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037995
- Sponsor's protocol ID
- KY2019-RWS(LD)
- Status last verified
- Jul 2019
- First submitted
- 14 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 28919116
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Study of End-stage Liver Disease in China
- ClinicalTrials.gov ID
- NCT04037995
- Acronym / sponsor ID
- KY2019-RWS(LD)
- Conditions
- End Stage Liver DIsease, Complication
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2020 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervationNo intervation | Other | – |
Primary outcome
Patient died during follow-up
Time frame: 3 years
Death occurred during 3 year
1 secondary outcome
Major events occurred during follow-up
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Background: PubMed 28919116GBD 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Liver DIsease and Complication, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingwen Ai, Doctor (13764990804 ext. 02152887969, JINGWENAI1990@126.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient died during follow-up (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04037995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.