Non-invasive tests to predict outcomes after curative treatment for hepatocellular carcinoma
Validation of Baveno VII Criteria and Spleen Stiffness Measurement on Outcome Prediction in Patients With Hepatocellular Carcinoma
This project will test whether regular non-invasive liver and spleen stiffness checks plus scheduled endoscopies can help predict future complications in people with compensated chronic liver disease who receive curative-intent treatment for HCC.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 159 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07036874 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with known chronic liver disease and a new HCC planned for curative-intent resection or local ablation who are compensated (no prior decompensation) and able to undergo transient elastography and endoscopy.
Not a fit: Patients with current or prior hepatic decompensation (Child C or prior decompensating events), prior HCC recurrence, planned liver transplantation, asplenism/splenectomy, or contraindications to endoscopy are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could identify patients at higher risk of portal hypertension and decompensation after HCC treatment without invasive testing, allowing earlier preventive care and targeted surveillance.
How similar studies have performed: Non-invasive measures like liver stiffness by VCTE and platelet count have been validated by Baveno VI/VII for ruling in or out clinically significant portal hypertension, but long-term outcome prediction specifically after curative HCC treatment is less well established.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.