Long-term Outcomes of Ablation, Liver Resection, and Liver Transplant as First-line Treatment for Solitary HCC of 3 cm or Less

Long-term Outcomes of Ablation, Liver Resection, and Liver Transplant as First-line Treatment for Solitary HCC of 3 cm or Less Using an Intention-to-treat Analysis: a Retrospective Cohort Study

Curative-intent therapies for hepatocellular carcinoma (HCC) include radiofrequency ablation (RFA), liver resection (LR), and liver transplantation (LT). Controversy exists in treatment selection for early-stage tumors. We sought to evaluate the oncologic outcomes of patients who received either RFA, LR, or LT as first-line treatment for solitary HCC ≤ 3cm in an intention-to-treat analysis.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Procedure: Radiofrequency ablation; Procedure: Liver resection; Procedure: Liver transplantation

• Study Type: Observational
• Enrollment (Actual): 119

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult (≥18 years) patients with solitary HCC ≤ 3cm who underwent either RFA, LR, or were listed for an LT between Feb-2000, and Nov-2018.

Description

Inclusion Criteria:

• Adult (≥18 years) patients
• Solitary HCC ≤ 3cm
• Receipt of either radiofrequency ablation, liver resection, or listing for a liver transplant
• Treatment received between Feb-2000 and Nov-2018

Exclusion Criteria:

• Pathology other than hepatocellular carcinoma (HCC)
• Receipt of prior treatment (i.e., not treatment naive)
• Not eligible for all of the three treatments (ablation, liver resection, or liver transplant listing)
• Platelet count <100,000 before treatment
• Alpha-1 fetoprotein (AFP) level > 1000 before treatment
• Age > 70 years
• Child-Pugh score C
• Esophageal varices grade greater than 2
• Model for End-stage Liver Disease (MELD) score before treatment exceeding 15
• Presence of ascites pretreatment
• Presence of encephalopathy pretreatment
• Spleen size greater than 12 cm

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Solitary HCC <= 3 cm; Treatment-naive patients with HCC <= 3 cm

Procedure: Radiofrequency ablation; Treatment-naive patients with solitary HCC <= 3 cm who received ablation as the first-line treatment; Procedure: Liver resection; Treatment-naive patients with solitary HCC <= 3 cm who underwent liver resection as the first-line treatment; Procedure: Liver transplantation; Treatment-naive patients with solitary HCC <= 3 cm who were listed for liver transplantation as the first-line treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intention-to-treat (ITT) overall survival	ITT was evaluated from the first treatment modality that was selected for curative intent. In the case of RFA and LR this was recorded as the time of the treatment. In the case of LT, the intention-to-treat was recorded at the time of listing for transplantation. The ITT analysis thus accounted for patients who were placed on the waitlist but dropped out.	Overall (median length of follow up of entire cohort 6.6 years)
Disease-free survival (DFS).	DFS was defined as the time after treatment during which the patient was alive and free of disease. For DFS, patients were censored at recurrence, death, or loss to follow up.	Overall (median length of follow up of entire cohort 6.6 years)

Collaborators and Investigators

• Sponsor: University Health Network, Toronto

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2000
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 21, 2021

Study Registration Dates

• First Submitted: December 31, 2021
• First Submitted That Met QC Criteria: December 31, 2021
• First Posted (Actual): January 14, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: radiofrequency ablation; hepatocellular carcinoma; liver transplant; liver resection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma, Hepatocellular; Hematinics; Liver Extracts
• Other Study ID Numbers: 16-5285.6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data that support the findings of this study are unsuitable to post given that they contain potentially identifiable patient information. Moreover, the research ethics board at the University Health Network has only approved data to be stored and analyzed by the members of the institutional study team to minimize any breach of patient confidentiality.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No