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

Purpose: The primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of 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

Optical Coherence Tomography: Current Applications for the Assessment of Coronary Artery Disease and Guidance of Percutaneous Coronary Interventions

Abstract Introduction Coronary angiography (CAG) is the standard modality for assessment of coronary stenoses and intraprocedural guidance of percutaneous coronary interventions (PCI). However, the limitations of CAG are well recognized. Intracoronary imaging (ICI) can potentially overcome these limitations. Intravascular ultrasound (IVUS) and optical coherence tomography (OCT) are the main ICI techniques utilized in clinical practice. Aim This narrative literature review addresses the current clinical applications of OCT in relation to IVUS and CAG in patients with coronary artery disease (CAD). Items reviewed are: technical implications of OCT and IVUS, lesion characterization and decision-making, stent optimization criteria, post-stenting results, safety in terms of procedural complications, clinical outcomes, and indications. Main Findings OCT is able to reveal more detail than IVUS due to its higher resolution. However, this higher resolution comes at the cost of a lower penetration depth. Pre-stenting OCT results in procedural change in more than 50% of the cases in terms of stent length and diameter. Post-stenting OCT resulting in stent optimization is reported in at least 27% of the cases. Malapposition and under-expansion are treated with post-dilatations, while edge dissections are treated with additional stent placement. Stent expansion, stent apposition, distal stent edge dissections, and reference lumen areas seem to be the most important stent optimization criteria for both decision-making and for reducing the risk of adverse events during follow-up. Both OCT and IVUS are superior in terms of post-stenting results compared with CAG alone. However, there is no consensus about whether OCT guidance results in better stent expansion than IVUS guidance. OCT, IVUS, and CAG are safe procedures with few reported procedural complications. In general, OCT guidance seems to contribute to favorable clinical outcomes compared with CAG guidance only. However, OCT guidance results in similar clinical outcomes as with IVUS guidance. OCT could be considered for lumen assessment and stent-related morphology in more complex cases in which CAG interpretation remains uncertain. Since OCT and IVUS have distinct characteristics, these techniques are complementary and should be considered carefully for each patient case based on the benefits and limitations of both techniques

Integration of Three-Dimensional Liver Models in a Multimodal Image-Guided Robotic Liver Surgery Cockpit

Background: Robotic liver surgery represents the most recent evolution in the field of minimally-invasive liver surgery. For planning and guidance of liver resections, surgeons currently rely on preoperative 2-dimensional (2D) CT and/or MR imaging and intraoperative ultrasonography. Translating 2D images into digital 3-dimensional (3D) models may improve both preoperative planning and surgical guidance. The da Vinci® robotic surgical system is a platform suitable for the integration of multiple imaging modalities into one single view. In this study, we describe multimodal imaging options and introduce the Robotic Liver Surgery Cockpit; Methods: in-house developed software was used and validated for segmentation and registration to create a virtual reality 3D model of the liver based on preoperative imaging. The accuracy of the 3D models in the clinical setting was objectively assessed in 15 patients by measuring tumor diameters and subjectively with a postoperative conducted questionnaire; Results: Implementation and applicability of the 3D model in the surgical cockpit was feasible in all patients and the quality of the 3D reconstructions was high in 14 (93%) of cases. Tumor diameters measured on CT and/or MR imaging were comparable to automated measurements using the segmentation software and 3D models; Conclusions: the 3D model was successfully incorporated in the robotic surgery console as part of a multimodality imaging platform and aided the surgeon in planning and guidance of the resection. Future studies should focus on further automation of 3D rendering and progress into augmented reality

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

Purpose: The primary objective is to determine the minimal ablation margin required to achieve a local recurrence rate of 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