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

Oosterveer, T.T.M.; Erp, G.C.M. van; Hendriks, P.; Broersen, A.; Overduin, C.G.; Rijswijk, C.S.P. van; Erkel, A.R. van; Meer, R.W. van der; Tushuizen, M.E.; Moelker, A.; Meijerink, M.R.; Delden, O.M. van; Jong, K.P. de; Leij, C. van der; Smits, M.L.J.; Urlings, T.A.J.; Braak, J.P.B.M.; Kranenbarg, E.M.K.; Duijn-de Vreugd, B. van; Zeijdner, E.; Goeman, J.J.; Futterer, J.J.; Coenraad, M.J.; Dijkstra, J.; Burgmans, M.C.

doi:doi:10.1007/s00270-022-03075-5

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 and Methods 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...Show morePurpose 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 and Methods 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 (similar to 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.Show less

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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