IC3 – The liver health trial

Trial summary
A major limitation preventing the early diagnosis of hepatocellular carcinoma (HCC) is the lack of awareness of cirrhosis which is the principal risk factor for HCC development. Cirrhosis is present in 85-95% of HCC patients but recognized in less than half. When diagnosed, cirrhosis patients benefit from an effective surveillance program of 6-monthly liver ultrasound with serum alpha-fetoprotein levels which increases early HCC diagnosis, curative treatment options and survival.

We have developed and validated accurate diagnostic tools for cirrhosis which are in routine clinical use in tertiary settings. We plan to implement these tools into a cirrhosis detection pathway which combines a serum test with liver elastography, into rural and urban primary care settings to improve HCC surveillance rates and detection of early HCC.

Using the framework of a multi-centre randomized controlled trial enrolling 2800 individuals over a 20 month period, we aim to achieve the following; 1) Compare the impact of a cirrhosis detection pathway versus usual care on the rate of HCC surveillance and early HCC incidence; 2) Determine the optimal cirrhosis pathway leading to HCC surveillance; and 3) Determine the cost-effectiveness and patient reported outcomes associated with a cirrhosis detection pathway compared to usual care.

Recruitment period
Proposed recruitment start date: March 2022
Proposed recruitment completion date: March 2024

Trial inclusion criteria
Age >45-75 years and any one of the following:
Type 2 diabetes
Obesity and hypertension
Obesity  and dyslipidaemia
Elevated liver enzymes in the last 12 months
Chronic viral hepatitis
Fatty liver (including steatohepatitis, non-alcoholic steatohepatitis and non-alcoholic liver disease)
Excess alcohol  use

In the IC3 trial the following definitions apply:
Hypertension: systolic blood pressure >130mmHg or a diastolic blood pressure >85mmHg or coded diagnosis of hypertension or prescription of an antihypertensive agent
Dyslipidaemia: triglycerides > 150 mg/dL (>1.70 mmol/L) or HDL-cholesterol <40mg/dL (<1.0  mmol/L) for men and <50 mg/dL (<1.3 mmol/L) for women)
Elevated liver enzymes: ALT: >30 in men >19 in women IU/l; AST > 45 IU/l; GGT > 60 IU/l

Trial exclusion criteria
Diagnosis of hepatocellular carcinoma and other terms for liver cancer including metastatic liver cancer ever recorded
Diagnosis of cirrhosis ever recorded
Diagnosis of ascites ever recorded
Diagnosis of oesophageal varices ever recorded
Patient living in nursing home

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Ethics approval

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