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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05193253
Enrollment
119
Registered
2022-01-14
Start date
2000-02-01
Completion date
2021-12-21
Last updated
2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular Carcinoma

Keywords

liver transplant, liver resection, radiofrequency ablation, hepatocellular carcinoma

Brief summary

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.

Interventions

PROCEDURERadiofrequency ablation

Treatment-naive patients with solitary HCC \<= 3 cm who received ablation as the first-line treatment

PROCEDURELiver resection

Treatment-naive patients with solitary HCC \<= 3 cm who underwent liver resection as the first-line treatment

PROCEDURELiver transplantation

Treatment-naive patients with solitary HCC \<= 3 cm who were listed for liver transplantation as the first-line treatment

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intention-to-treat (ITT) overall survivalOverall (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).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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026