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

November 14, 2025 updated by: National Cancer Centre, Singapore

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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).

Study Type

Observational

Enrollment (Actual)

1043

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 168583
        • National Cancer Centre, Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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).

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At least 5 years.
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 (%).
Through study completion, an average of 3 years.
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.
Through study completion, an average of 3 years.
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.
Minimum 2 years follow up after Hepatocellular carcinoma resection.
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.
Minimum 2 years follow up after Hepatocellular carcinoma resection.
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.
Minimum 2 years follow up after Hepatocellular carcinoma resection.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Collaborators

Singapore General Hospital

Investigators

  • Principal Investigator: Pierce Chow, MD, PhD, National Cancer Centre, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 17, 2017

Primary Completion (Actual)

June 30, 2020

Study Completion (Actual)

June 30, 2020

Study Registration Dates

First Submitted

February 26, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

November 18, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-2601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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