Health TrialsbyHealthPanel

Natural History of Advanced Chronic Liver Diseases

ConditionsCirrhosisAdvanced Chronic Liver Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese University of Hong Kong

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 or above

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.

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transient elastography

    Diagnostic test

    Liver stiffness and spleen stiffness from transient elastography

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patients with advanced chronic liver disease1 intervention

Trial outcomes

Primary outcomes

1

Incident hepatic events and liver-related mortality

Incident hepatic events (including ascites, variceal bleeding and overt hepatic encephalopathy) and liver-related mortality

Time frame
10 years

Secondary outcomes

1

Incidence rate of each hepatic event

Hepatic events include ascites, variceal bleeding and overt hepatic encephalopathy

Time frame
10 years
2

Incidence rate of hepatocellular carcinoma

Development of hepatocellular carcinoma

Time frame
10 years
3

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

Time frame
10 years
4

Change in liver and spleen stiffness

Change in liver and spleen stiffness by transient elastography

Time frame
10 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chinese University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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