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

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: Radiofrequency ablation; Procedure: Liver resection; Procedure: Liver transplantation

• Registration Number: NCT05193253
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-02-01
• Primary Completion: 2018-11-30
• Status Verified: 2021-12
• Study Completion: 2021-12-21
• Study First Submitted: 2021-12-31
• Study First Submitted QC: 2021-12-31
• Study First Posted: 2022-01-14
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Solitary HCC <= 3 cm	Radiofrequency ablation	Treatment-naive patients with HCC \<= 3 cm
Solitary HCC <= 3 cm	Liver transplantation	Treatment-naive patients with HCC \<= 3 cm
Solitary HCC <= 3 cm	Liver resection	Treatment-naive patients with HCC \<= 3 cm

Primary Outcome Measures

Name	Time	Method
Intention-to-treat (ITT) overall survival	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).	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.