Non-invasive Assessment for Outcome Prediction in Patients With Hepatocellular Carcinoma
Validation of Baveno VII Criteria and Spleen Stiffness Measurement on Outcome Prediction in Patients With Hepatocellular Carcinoma
Chinese University of Hong Kong
159 participants
Nov 4, 2024
OBSERVATIONAL
Conditions
Summary
This is a single-centre, prospective cohort study. Consecutive patients with compensated liver disease and hepatocellular carcinoma (HCC) for curative-intent treatment will be invited to this study. The study follow-up duration will be five years. The primary outcome is the composite of incident high-risk varices, hepatic decompensation and liver-related mortality. The participants will undergo transient elastography at baseline and then half-yearly post-HCC curative treatment; and oesophagogastroduodenoscopy (OGD) at baseline and then at year 1, 3 and 5 post-HCC curative treatment. Clinical assessments and laboratory tests will also be done at baseline and every 6 months until year 5 to identify any clinical events.
Eligibility
Inclusion Criteria3
- 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 Criteria10
- 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
Interventions
Liver and spleen stiffness will be measured by transient elastography. Varices will be identified by oesophagogastroduodenoscopy.
Locations(1)
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NCT07036874