Non-invasive tests to predict outcomes after curative treatment for hepatocellular carcinoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-centre, prospective cohort of consecutive adults with compensated chronic liver disease and newly diagnosed HCC planned for curative-intent resection or local ablation, followed for five years. Participants will undergo vibration-controlled transient elastography (liver and spleen stiffness) at baseline and every six months, with oesophagogastroduodenoscopy at baseline and at years 1, 3, and 5, alongside routine clinical and laboratory assessments every six months. The primary outcome is a composite of incident high-risk varices, hepatic decompensation, and liver-related death. The study aims to determine whether these non-invasive measurements can predict clinically important liver-related events after curative HCC treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18 or above
* Known chronic liver disease(s)
* HCC for curative-intent treatment (defined by HCC diagnosed with typical radiological features or histology, and planned for surgical resection or local ablative therapy as a curative-intent treatment)

Exclusion Criteria:

* Current or history of decompensated liver cirrhosis (i.e. Child's C cirrhosis, prior decompensating events such as ascites, variceal bleeding, hepatic encephalopathy and hepatorenal syndrome)

  o Child's B cirrhosis without decompensating events is not excluded
* Past history of HCC (ie. The current HCC is a recurrence of priorly treated HCC or a second de novo HCC after previous first HCC)
* Non-primary liver tumour (such as secondary liver tumour due to metastasis from another distant primary tumour)
* History of liver transplantation or plan for liver transplantation as the modality of curative-intent HCC treatment
* Asplenism or history of splenectomy
* Contraindication to OGD (eg. Intestinal perforation of obstruction)
* Serious medical illness with limited life expectancy of less than 6 months
* Pregnancy
* Unable to obtain or refusal of informed consent from patient

Where it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.