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OpenTrials
Completed

NCT Number: NCT05193253

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

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Radiofrequency ablation

Procedure

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

liver resection

Procedure

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

Liver Transplantation

Procedure

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2018
Study completion
2021
First posted
Jan 14, 2022
Registry last updated
Jan 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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