Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis | — | UNRESOLVED | — |
| HCC - Hepatocellular Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| transient elastography and oesophagogastroduodenoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with hepatocellular carcinoma
- description
- Adult patients with known chronic liver disease and hepatocellular carcinoma planning for curative-intent treatment
- interventionNames
- Diagnostic Test: transient elastography and oesophagogastroduodenoscopy
Primary outcomes (1)
- measure
- Composite of incident high-risk varices, hepatic decompensation and liver-related mortality
- timeFrame
- 5 years
- description
- Composite of incident high-risk varices, hepatic decompensation and liver-related mortality
Secondary outcomes (4)
- measure
- Development of each hepatic decompensation event
- timeFrame
- 5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available