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

Autor: Timo T. M. Oosterveer, Gonnie C. M. van Erp, Pim Hendriks, Alexander Broersen, Christiaan G. Overduin, Carla S. P. van Rijswijk, Arian R. van Erkel, Rutger W. van der Meer, Maarten E. Tushuizen, Adriaan Moelker, Martijn R. Meijerink, Otto M. van Delden, Koert P. de Jong, Christiaan van der Leij, Maarten L. J. Smits, Thijs A. J. Urlings, Jeffrey P. B. M. Braak, Elma Meershoek-Klein Kranenbarg, Bianca van Duijn-de Vreugd, Evelijn Zeijdner, Jelle J. Goeman, Jurgen J. Fütterer, Minneke J. Coenraad, Jouke Dijkstra, Mark C. Burgmans
Přispěvatelé: Radiology and nuclear medicine, CCA - Cancer Treatment and quality of life, ACS - Pulmonary hypertension & thrombosis, Cancer Center Amsterdam, Amsterdam Gastroenterology Endocrinology Metabolism, Amsterdam Cardiovascular Sciences, Radiology and Nuclear Medicine, CCA - Cancer Treatment and Quality of Life, RS: Carim - B06 Imaging, MUMC+: DA BV Medisch Specialisten Radiologie (9), Guided Treatment in Optimal Selected Cancer Patients (GUTS), Groningen Institute for Organ Transplantation (GIOT), Radiology & Nuclear Medicine
Rok vydání: 2022
Předmět:
Zdroj: Cardiovascular and Interventional Radiology, 45, 5, pp. 606-612
CardioVascular and Interventional Radiology, 45(5), 606-612. Springer Verlag
Cardiovascular and Interventional Radiology, 45, 606-612
CardioVascular and Interventional Radiology, 45, 606-612. SPRINGER
Cardiovascular and interventional radiology, 45(5), 606-612. Springer Verlag
Cardiovascular and Interventional Radiology, 45(5), 606-612. Springer, Cham
Cardiovascular and interventional radiology, 45(5), 606-612. SPRINGER
Oosterveer, T T M, van Erp, G C M, Hendriks, P, Broersen, A, Overduin, C G, van Rijswijk, C S P, van Erkel, A R, van der Meer, R W, Tushuizen, M E, Moelker, A, Meijerink, M R, van Delden, O M, de Jong, K P, van der Leij, C, Smits, M L J, Urlings, T A J, Braak, J P B M, Meershoek-Klein Kranenbarg, E, van Duijn-de Vreugd, B, Zeijdner, E, Goeman, J J, Fütterer, J J, Coenraad, M J, Dijkstra, J & Burgmans, M C 2022, ' 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 ', CardioVascular and Interventional Radiology, vol. 45, no. 5, pp. 606-612 . https://doi.org/10.1007/s00270-022-03075-5
CardioVascular and Interventional Radiology, 45(5), 606-612. Springer-Verlag
ISSN: 0174-1551
Popis: Purpose The primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of 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 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.
Databáze: OpenAIRE
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