Clinical trial NCT06294808: Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC
Official title: Predicting Survival After Surgical Resection for the Entire Spectrum of Anatomically Resectable HCC: a Metroticket Approach
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma Resectable
Keywords: Metroticket Approach
Surgical Resection
Hepatocellular Carcinoma (HCC)
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2024-03-06
Enrollment: 1043
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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).

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 5-year mortality.
timeFrame: At least 5 years.
measure: Concordance of pre-operative radiological and post operative surgical specimen.
timeFrame: Through study completion, an average of 3 years.
measure: Agreement between TBI calculated from pre-operative imaging versus those obtained from post-surgical pathological assessment.
timeFrame: Through study completion, an average of 3 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre, Singapore
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
affiliation: National Cancer Centre, Singapore
name: Pierce Chow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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