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

Study Overview
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Brief Summary
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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.

Official Title
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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 Using an Intention-to-treat Analysis: a Retrospective Cohort Study

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: Radiofrequency ablation
* Procedure: Liver resection
* Procedure: Liver transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Solitary HCC <= 3 cm<br>Treatment-naive patients with HCC <= 3 cm | Procedure: Radiofrequency ablation<br>* Treatment-naive patients with solitary HCC <= 3 cm who received ablation as the first-line treatment<br>Procedure: Liver resection<br>* Treatment-naive patients with solitary HCC <= 3 cm who underwent liver resection as the first-line treatment<br>Procedure: Liver transplantation<br>* Treatment-naive patients with solitary HCC <= 3 cm who were listed for liver transplantation as the first-line treatment<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hepatocellular carcinoma, liver transplant, liver resection, radiofrequency ablation