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

Hepatocellular Carcinoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05193253
• Other study ID #: 16-5285.6
• Status: Completed
• Start date: February 1, 2000
• Est. completion date: December 21, 2021

Study information

• Verified date: December 2021
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: December 21, 2021
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Procedure:
• Radiofrequency ablation
Treatment-naive patients with solitary HCC <= 3 cm who received ablation as the first-line treatment
• Liver resection
Treatment-naive patients with solitary HCC <= 3 cm who underwent liver resection as the first-line treatment
• Liver transplantation
Treatment-naive patients with solitary HCC <= 3 cm who were listed for liver transplantation as the first-line treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)