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

NCT05193253 | Completed

• 1 other identifier: 16-5285.6
• Study Type: observational
• Target: 119
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatocellular Carcinoma

Keywords

liver transplant; liver resection; radiofrequency ablation; hepatocellular carcinoma

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (1)

Solitary HCC <= 3 cm

Treatment-naive patients with HCC \<= 3 cm

Procedure: Radiofrequency ablation; Procedure: Liver resection; Procedure: Liver transplantation

Interventions

Radiofrequency ablation PROCEDURE

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

Solitary HCC <= 3 cm

Liver resection PROCEDURE

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

Solitary HCC <= 3 cm

Liver transplantation PROCEDURE

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

Solitary HCC <= 3 cm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult (≥18 years) patients with solitary HCC ≤ 3cm who underwent either RFA, LR, or were listed for an LT between Feb-2000, and Nov-2018.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Radiofrequency Ablation; Hepatectomy; Liver Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Digestive System Surgical Procedures; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Organ Transplantation; Transplantation

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2021
• First Posted: January 14, 2022
• Study Start: February 1, 2000
• Primary Completion: November 30, 2018
• Study Completion: December 21, 2021
• Last Updated: January 18, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share