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This is a retrospective-prospective registry cohort study. Patients with advanced chronic liver disease (ACLD) will be prospectively invited to this study. The study follow-up duration will be 10 years. The primary outcome is incident hepatic events and liver-related mortality. Participants will undergo annual transient elastography examination.
Chronic liver diseases (CLD) has burdened the global healthcare system throughout the years. Among all causes of CLD, chronic hepatitis B (CHB) is generally the commonest cause of CLD in the Asia-Pacific region but the prevalence is expected to decline due to effective antiviral treatment. Similarly, with the introduction of direct-acting antiviral (DAA), chronic hepatitis C (CHC) is now readily curable. On the other hand, an increasing trend is observed in metabolic dysfunction-associated steatotic liver disease (MASLD) and alcohol-related liver disease (ARLD) which is likely to change the landscape of CLD both in the region and worldwide.
Advanced chronic liver disease (ACLD) or cirrhosis is a final common pathway of all CLD and was the 9th and 15th leading cause of death in Southeast Asia (0.42 million deaths) in 2019 as reported by the World Health Organization (WHO) Global Health Estimates. It also significantly increases the risk of hepatocellular carcinoma (HCC). With its significant impact on morbidity and mortality, the prognosis of compensated and decompensated states differ drastically and the field is pushing forward ways to prevent hepatic decompensation in order to improve liver-related outcomes. Non-selective beta-blockers (NSBB) has been shown to reduce risk of hepatic decompensation in patients with compensated advanced chronic liver disease (cACLD) and concomitant clinically significant portal hypertension (CSPH). Some other drugs including angiotensin converting enzyme inhibitor (ACEI)/angiotensin-receptor blocker (ARB), statin etc. have been shown in retrospective studies to reduce risk of hepatic decompensation but more evidence is required to draw conclusive interpretation.
Apart from medications, non-invasive tests (NIT), including liver stiffness measurement (LSM) and spleen stiffness measurement (SSM) from vibration-controlled transient elastography (VCTE) help prognosticate chronic liver diseases. Yet more validation is required on certain conditions such as in patients with obesity as well as HCC. Biomarkers are also under the spotlights for risk prediction but are yet to reach the stage for widespread clinical practice. Hence these areas deserve further studies.
Hong Kong is an area endemic for chronic hepatitis B as well as expected for an increase with MASLD and ARLD. There has not been an established registry to capture these ACLD patients for systematic monitoring and analysis. Thus, a registry for ACLD is imperative.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with advanced chronic liver disease | Adult patients with advanced chronic liver disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transient elastography | Diagnostic Test | Liver stiffness and spleen stiffness from transient elastography |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incident hepatic events and liver-related mortality | Incident hepatic events (including ascites, variceal bleeding and overt hepatic encephalopathy) and liver-related mortality | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of each hepatic event | Hepatic events include ascites, variceal bleeding and overt hepatic encephalopathy | 10 years |
| Incidence rate of hepatocellular carcinoma | Development of hepatocellular carcinoma |
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Inclusion Criteria:
Aged 18 or above
Known ACLD, defined by:
Exclusion Criteria:
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The prospective cohort will comprise of consecutive patients with advanced chronic liver disease attending hepatology clinics or in-patient care in Prince of Wales Hospital in Hong Kong. All patients will be screened if the eligibility criteria are fulfilled.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jimmy CT Lai, MB ChB | Contact | 85235054205 | jimmyctlai@cuhk.edu.hk | |
| Angel Chim, MSc | Contact | 85235054205 | angelchim@cuhk.edu.hk |
| Name | Affiliation | Role |
|---|---|---|
| Jimmy CT Lai, MB ChB | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Hong Kong | Hong Kong |
Data may be shared upon reasonable request.
6 months after the first publication until 15 years after the end of the study
By email communication.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 23, 2024 | Jun 17, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 23, 2024 | Jun 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Store 10 mL of clotted blood and 10 mL of EDTA blood for exploration or novel biomarkers, future genetic and biochemical research
| 10 years |
| Changes in Child-Pugh and Model for End-stage Liver Disease scores | The minimum and maximum Child-Pugh score are 5 and 15, respectively. The minimum and maximum Model for End-stage Liver Disease score are 6 and 40, respectively. A higher score denotes worse outcome in both scores | 10 years |
| Change in liver and spleen stiffness | Change in liver and spleen stiffness by transient elastography | 10 years |
| Exploratory outcome on identification of novel biomarkers | Novel biomarkers include multi-omics exploration in relation to the primary outcome. | 10 years |