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NCT Number: NCT06294808

Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC

Clinical outcomes after surgical resection in HCC is a continuum and is clearly related to tumor burden but needs better definition. The researchers describe the use of the "metro ticket" approach to analyze surgical outcomes over the whole spectrum of anatomically resectable HCC to define overall survival including intermediate stage tumors (BCLC B). The analysis the researchers provide in this study enables the clinician to select the optimal surgical resection candidate based on robust long term survival data.

In addition, study compares outcome for open surgery vs laparoscopic surgery, survival outcome for viral and non-viral HCC using Albumin-Bilirubin (ALBI) for more comprehensive study result.

On top of that, non-HBV, non-HCV (NBNC) hepatocellular carcinoma (HCC) is generally associated with poorer tumor characteristics. However, it remains unclear whether this leads to worse post-resection survival compared to viral-related HCC. This study evaluates the prognostic impact of viral status and liver function on post-resection survival outcomes between NBNC and viral HCC patients.

This retrospective study also aims to determine if HCC of viral and non-viral etiologies have different clinical outcomes after surgical resection when tumor burden and liver function are considered.

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Key information

Conditions

Hepatocellular Carcinoma Resectable Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Centre, Singapore, Singapore

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About this study

Patients who underwent surgical resection (both open surgery and laparoscopic surgery) for HCC from 1st January 2000 to 30th June 2018 by the joint hepato-pancreato-biliary surgery service at the Singapore Healthcare Group of Hospitals (Singapore General Hospital and the National Cancer Centre Singapore) were retrospectively identified from a prospectively kept institutional database.

The assessment of the size, number of nodules and vascular invasion of HCC were based on pre-operative CT/MRI imaging and pathological assessment of the resected specimens. All resections were histologically confirmed as HCC. Patients with macrovascular invasion and extrahepatic invasion were excluded from analysis as were patients resected for other palliative intents (e.g. ruptured HCC).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Unequivocal diagnosis of Hepatocellular Carcinoma (HCC) by histology
  • Patients who underwent surgical resection for HCC

Exclusion criteria

  • Patients who underwent liver resection for other malignancies ie cholangiocarcinoma
  • Patients with HCC who did not undergo liver resection.
  • Patients with HCC who underwent liver transplant.

Treatment and study plan

Primary outcomes

  1. 5-year mortality.

    Time frame: At least 5 years.

    Time between the respective surgery to the time of death. Bivariate contour plots of 5-year survival probability as a function of X = AFP concentration (ng/mL) and Y = tumor burden index (size of largest nodule + 2*number of nodules) (TBI) were obtained as smoothed contours originating from an empirically-derived bivariate 5-year survival distribution S(X,Y)=1- F(x ≤X,y ≤Y). The function F(x ≤X,y ≤Y) is the empirical, bivariate cumulative distribution of 5-year mortality as a function of X and Y defined over the domain (0<X≤5000,1≤Y≤15) in our patient cohort. All patients in our study cohort were followed up for at least 5 years following respective surgery which allowed estimation of actual all-cause 5-year mortality.

  2. Concordance of pre-operative radiological and post operative surgical specimen.

    Time frame: Through study completion, an average of 3 years.

    The metro ticket modeling was based on tumour size and number of nodules extracted at pre-operative radiological imaging and post surgical pathology assessment. Continuous variables are summarized as mean, standard deviation, 25th and 75th percentiles, median and minimum and maximum. Categorical variables are summarized as counts (N) and percentages (%).

  3. Agreement between TBI calculated from pre-operative imaging versus those obtained from post-surgical pathological assessment.

    Time frame: Through study completion, an average of 3 years.

    Bland-Altman analysis, which is based on a simple but effective graphical approach for evaluating bias and for calculating bounds on the expected magnitude of the individual differences arising between the two measurement methods, is used. A 45° line of identity with scatter plot was produced to display the correlation between the 2 measurements. Bias was evaluated by calculating (d) ̅ the mean difference of the measurements. Limits of agreement, calculated as (d) ̅ ±2sd , where sd is the standard deviation of the individual differences, defined bounds within which 95% of the measurement differences are expected to fall. The B-A plot defines the limits of agreements. B-A analysis is performed using TBI over a wide range, 0 ≤ TBI ≤ 30, and a restricted range focusing on small tumors, 0 < TBI ≤ 6.

  4. Overall survival (OS) stratified on hepatitis status.

    Time frame: Minimum 2 years follow up after Hepatocellular carcinoma resection.

    The time elapsed from the surgical resection to the point of death or the last follow-up, whichever occurred first.

  5. Recurrence-free survival (RFS) stratified on hepatitis status.

    Time frame: Minimum 2 years follow up after Hepatocellular carcinoma resection.

    The time between surgical resection of HCC and its recurrence confirmed via multi-phasic CT or MRI imaging, or last follow-up, whichever occurred first.

  6. Prognostic stratification according to ALBI grade.

    Time frame: Minimum 2 years follow up after Hepatocellular carcinoma resection.

    Overall survival (OS) and Recurrence-free survival (RFS) stratified according to ALBI grade.

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Collaborators

  • Singapore General Hospital

Registry information

Official study title

Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC: a Metroticket Approach

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 6, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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