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

NCT ID: NCT05193253

Last Updated: 2022-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-02-01

Study Completion Date

2021-12-21

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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Solitary HCC <= 3 cm

Treatment-naive patients with HCC \<= 3 cm

Radiofrequency ablation

Intervention Type PROCEDURE

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

Liver resection

Intervention Type PROCEDURE

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

Liver transplantation

Intervention Type PROCEDURE

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

Interventions

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Radiofrequency ablation

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

Intervention Type PROCEDURE

Liver resection

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

Intervention Type PROCEDURE

Liver transplantation

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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16-5285.6

Identifier Type: -

Identifier Source: org_study_id

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