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NCT07036874
Non-invasive Assessment for Outcome Prediction in Patients With Hepatocellular Carcinoma
Conditions: HCC - Hepatocellular Carcinoma, Cirrhosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 159
Sponsor: Chinese University of Hong Kong
Location: Prince of Wales Hospital Hong Kong
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 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
Source: ClinicalTrials.gov (NCT07036874). StuddyBuddy aggregates publicly available trial information.