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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Retrospective
  • Study Primary Completion Date: November 30, 2018

Interventions

  • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Intention-to-treat (ITT) overall survival
    • Time Frame: Overall (median length of follow up of entire cohort 6.6 years)
    • 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.
  • Disease-free survival (DFS).
    • Time Frame: Overall (median length of follow up of entire cohort 6.6 years)
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • 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 were included. Exclusion Criteria:

  • Patients were excluded if they had pathology other than HCC, had received previous treatments, or were not eligible for all of the three treatments – To ensure inclusion of patients theoretically eligible for either RFA, LR, or LT we excluded patients with a platelet count <100,000 before treatment, 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 or encephalopathy pretreatment, and a spleen size exceeding 12 cm.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Health Network, Toronto
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.