Non-invasive Assessment for Outcome Prediction in Patients With Hepatocellular Carcinoma
Recruiting now
Conditions studied: HCC - Hepatocellular Carcinoma, Cirrhosis
In brief
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.
Key facts
- Study ID
- NCT07036874
- Run by
- Chinese University of Hong Kong
- People needed
- 159
- Starts
- 2024-11-04
- Expected to finish
- 2030-12-01
- Last updated by the study team
- 2025-06-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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 is running
- Prince of Wales Hospital — Hong Kong, Hong Kong (enrolling)
Full record on ClinicalTrials.gov
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