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 - Funding Information: The PROMETHEUS trial is a prospective, multicenter, non-experimental, non-comparative, open-label study. The sponsor of the study is the Leiden University Medical Center (LUMC). This study is a collaboration between Dutch academic centers and cancer organizations. The trial is funded by the Dutch Cancer Society and registered at https://www.trialregister.nl (ID: NL9713). Funding Information: This study is funded by the Dutch Cancer Society (KWF, Grant Number 12879). Funding Information: M.C. Burgmans has received a speaker honorarium and a research grant from Medtronic, and an educational grant from Boston Scientific. None are related to the current project. J.J. Fütterer is advisory board member at NDR and is participating in the NOLA study from J&J. None are related to the current project. All other authors declare that they have no conflict of interest. Publisher Copyright: © 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 - Local recurrence
KW - Minimal ablation margin
KW - Thermal ablation
UR - http://www.scopus.com/inward/record.url?scp=85125938194&partnerID=8YFLogxK
U2 - https://doi.org/10.1007/s00270-022-03075-5
DO - https://doi.org/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 -