Study Protocol PROMETHEUS: Prospective Multicenter Study to Evaluate the Correlation Between Safety Margin and Local Recurrence After Thermal Ablation Using Image Co-registration in Patients with Hepatocellular Carcinoma.
Cardiovasc Intervent Radiol
; 45(5): 606-612, 2022 May.
Article
em En
| MEDLINE
| ID: mdl-35233662
ABSTRACT
PURPOSE:
The primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of < 10% in patients with hepatocellular carcinoma undergoing thermal ablation. Secondary objectives are to analyze the correlation between ablation margins and local recurrence and to assess efficacy. MATERIALS ANDMETHODS:
This study is a prospective, multicenter, non-experimental, non-comparative, open-label study. Patients > 18 years with Barcelona Clinic Liver Cancer stage 0/A hepatocellular carcinoma (or B with a maximum of two lesions < 5 cm each) are eligible. Patients will undergo dual-phase contrast-enhanced computed tomography directly before and after ablation. Ablation margins will be quantitatively assessed using co-registration software, blinding assessors (i.e. two experienced radiologists) for outcome. Presence and location of recurrence are evaluated independently on follow-up scans by two other experienced radiologists, blinded for the quantitative margin analysis. A sample size of 189 tumors (~ 145 patients) is required to show with 80% power that the risk of local recurrence is confidently below 10%. A two-sided binomial z-test will be used to test the null hypothesis that the local recurrence rate is ≥ 10% for patients with a minimal ablation margin ≥ 2 mm. Logistic regression will be used to find the relationship between minimal ablation margins and local recurrence. Kaplan-Meier estimates are used to assess local and overall recurrence, disease-free and overall survival.DISCUSSION:
It is expected that this study will result in a clear understanding of the correlation between ablation margins and local recurrence. Using co-registration software in future patients undergoing ablation for hepatocellular carcinoma may improve intraprocedural evaluation of technical success. Trial registration The Netherlands Trial Register (NL9713), https//www.trialregister.nl/trial/9713 .Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Ablação por Cateter
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Carcinoma Hepatocelular
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Neoplasias Hepáticas
Tipo de estudo:
Clinical_trials
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Observational_studies
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Risk_factors_studies
Limite:
Humans
Idioma:
En
Revista:
Cardiovasc Intervent Radiol
Ano de publicação:
2022
Tipo de documento:
Article
País de afiliação:
Holanda