TY - JOUR
T1 - Study Protocol PROMETHEUS
T2 - 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
AU - Oosterveer, Timo T M
AU - van Erp, Gonnie C M
AU - Hendriks, Pim
AU - Broersen, Alexander
AU - Overduin, Christiaan G
AU - van Rijswijk, Carla S P
AU - van Erkel, Arian R
AU - van der Meer, Rutger W
AU - Tushuizen, Maarten E
AU - Moelker, Adriaan
AU - Meijerink, Martijn R
AU - van Delden, Otto M
AU - de Jong, Koert P
AU - van der Leij, Christiaan
AU - Smits, Maarten L J
AU - Urlings, Thijs A J
AU - Braak, Jeffrey P B M
AU - Meershoek-Klein Kranenbarg, Elma
AU - van Duijn-de Vreugd, Bianca
AU - Zeijdner, Evelijn
AU - Goeman, Jelle J
AU - Fütterer, Jurgen J
AU - Coenraad, Minneke J
AU - Dijkstra, Jouke
AU - Burgmans, Mark C
N1 - © 2022. The Author(s).
PY - 2022/5
Y1 - 2022/5
N2 - 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 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 .
AB - 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 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 .
KW - Co-registration
KW - Hepatocellular carcinoma
KW - LIVER-TUMORS
KW - Local recurrence
KW - MICROWAVE ABLATION
KW - Minimal ablation margin
KW - POSTPROCEDURE CT
KW - PREPROCEDURE
KW - RADIOFREQUENCY ABLATION
KW - Thermal ablation
U2 - 10.1007/s00270-022-03075-5
DO - 10.1007/s00270-022-03075-5
M3 - Article
C2 - 35233662
SN - 0174-1551
VL - 45
SP - 606
EP - 612
JO - Cardiovascular and Interventional Radiology
JF - Cardiovascular and Interventional Radiology
IS - 5
ER -