Natural course of advanced chronic liver disease (cirrhosis)
Natural History of Advanced Chronic Liver Diseases and Factors Associated With Hepatic Events - a Registry Study
We will follow adults with advanced chronic liver disease for 10 years and use yearly transient elastography to see if and when liver complications or liver-related death occur.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07042308 on ClinicalTrials.gov |
What this trial studies
This is a retrospective-prospective registry that enrolls adults with advanced chronic liver disease or cirrhosis and follows them for up to 10 years. Participants undergo annual transient elastography to measure liver stiffness and clinical data are collected to record incident hepatic events and liver-related mortality. The primary outcomes are new hepatic events and liver-related death, with collected data used to characterize progression patterns and risk factors. Enrollment and follow-up take place at Prince of Wales Hospital in Hong Kong with standard exclusion criteria applied.
Who should consider this trial
Good fit: Adults aged 18 or older with confirmed advanced chronic liver disease or liver stiffness >10 kPa who can provide consent and attend yearly visits are ideal candidates.
Not a fit: People with prior hepatocellular carcinoma, prior liver transplant, asplenia, pregnancy, very limited life expectancy, or inability/refusal to consent are excluded and unlikely to benefit.
Why it matters
Potential benefit: If successful, the registry could improve prediction of who will develop liver complications and guide timing of preventive treatments.
How similar studies have performed: Other longitudinal cohorts using transient elastography have helped predict decompensation risk, though long-term regional registries like this remain less common.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 or above * Known ACLD, defined by: * LSM \> 10kPa or * Clinical cirrhosis, suggested by 1. ultrasonography of the hepatobiliary system shows features of cirrhosis (e.g. shrunken and nodular liver) and portal hypertension (e.g. dilated portal vein, portal-systemic collaterals or varices, splenomegaly, ascites). 2. Oesophagogastroduodenoscopy (OGD) shows presence of oesophageal varices (OV) and/or gastric varices (GV) and/or portal hypertensive gastropathy. Exclusion Criteria: * Current or past history of hepatocellular carcinoma (HCC) * History of liver transplantation * Asplenism or history of splenectomy * Serious medical illness with limited life expectancy of less than 6 months * Pregnancy * Unable to obtain or refusal of informed consent from patient
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Jimmy CT Lai, MB ChB — Chinese University of Hong Kong
- Study coordinator: Jimmy CT Lai, MB ChB
- Email: jimmyctlai@cuhk.edu.hk
- Phone: 85235054205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.