Cirrhosis and Chronic Liver Disease
Conditions
Keywords
Cirrhosis, Decompensation, Acute-on-chronic liver failure, Death
Brief summary
The purpose of this study is to identify factors that predict the development of decompensation, acute-on-chronic liver failure (ACLF) and death in patients with liver cirrhosis. Clinical data will be retrieved from existing hospital records. This information may help doctors to identify patients with cirrhosis who are at risk of deterioration earlier (before they develop complications) and to develop effective treatment strategies to prevent or delay these complications. This study is designed as a prospective, non-interventional, observational study. This means that if you agree to participate in the study, you will not be required to undergo any additional hospital visits, tests, procedures or interventions other than the usual standard-of-care management that your doctor will provide. If you consent to participate in this study, you will be providing the study investigators permission to review and analyse your clinical data from the hospital clinical records. Your data will be collected throughout the course of your disease until liver transplantation or death.
Detailed description
The primary aim of this study is to prospectively identify factors that predict decompensation, ACLF and death in patients with cirrhosis. Specific goals of the study: * To study the 1-, 3- and 5-year risk of decompensation, ACLF and death in patients with compensated and decompensated liver cirrhosis in Singapore * To identify clinically relevant point-in-time predictors and biomarkers for liver decompensation in general, and for specific liver-related events (including variceal bleeding, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, portal vein thrombosis, portopulmonary hypertension, hepatopulmonary syndrome, cirrhotic cardiomyopathy, hepatorenal syndrome, refractory ascites, sarcopenia, and liver cancer) * To study the impact of underlying etiology of liver disease on the rate of decompensation, ACLF and death in liver cirrhosis * To provide external validation of predictive scores for decompensation (ALBI, CHESS-ALARM, LSPS, PREDICT, etc). * To serve as a core (hub) study for prospective ancillary studies regarding diagnosis, prognosis, and pathogenesis of AD and ACLF
Interventions
OTHERObservation
Patients with liver cirrhosis will be observed to monitor for death
Sponsors
Singapore General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with clinical diagnosis of liver cirrhosis 2. Age 18 years and above (parental consent required if below 21 years) 3. Willing and able to provide informed consent
Exclusion criteria
* No clinical evidence of liver cirrhosis * Not willing to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause mortality | Up to 10 years from date of enrollment | Death from any cause will be recorded during the study period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Decompensation of liver cirrhosis | 10 years | Occurence of first episode of hepatic decompensation, defined as the development of any of the following clinical events: variceal bleeding, hepatic encephalopathy, ascites, hepatocellular carcinoma, portal vein thrombosis, sepsis and acute-on-chronic liver failure (ACLF). Diagnosis will be based on standard clinical, laboratory or imaging criteria. These data will be retrieved from hospital clinical records. |
Countries
Singapore
Contacts
CONTACTJason Pik Eu Chang, MBBS, MRCP
Outcome results
None listed