OBJECTIVES To evaluate the accuracy and clinical integrability of a comprehensive simulation tool to plan and predict radiofrequency ablation (RFA) zones in liver tumors. METHODS Forty-five patients with 51 malignant hepatic lesions of different origins were included in a prospective multicenter trial. Prior to CT-guided RFA, all patients underwent multiphase CT which included acquisitions for the assessment of liver perfusion. These data were used to generate a 3D model of the liver. The intra-procedural position of the RFA probe was determined by CT and semi-automatically registered to the 3D model. Size and shape of the simulated ablation zones were compared with those of the thermal ablation zones segmented in contrast-enhanced CT images 1 month after RFA; procedure time was compared with a historical control group. RESULTS Simulated and segmented ablation zone volumes showed a significant correlation (ρ = 0.59, p < 0.0001) and no significant bias (Wilcoxon's Z = 0.68, p = 0.25). Representative measures of ablation zone comparison were as follows: average surface deviation (absolute average error, AAE) with 3.4 ± 1.7 mm, Dice similarity coefficient 0.62 ± 0.14, sensitivity 0.70 ± 0.21, and positive predictive value 0.66 ± 0. There was a moderate positive correlation between AAE and duration of the ablation (∆t; r = 0.37, p = 0.008). After adjustments for inter-individual differences in ∆t, liver perfusion, and prior transarterial chemoembolization procedures, ∆t was an independent predictor of AAE (ß = 0.03 mm/min, p = 0.01). Compared with a historical control group, the simulation added 3.5 ± 1.9 min to the procedure. CONCLUSION The validated simulation tool showed acceptable speed and accuracy in predicting the size and shape of hepatic RFA ablation zones. Further randomized controlled trials are needed to evaluate to what extent this tool might improve patient outcomes. KEY POINTS • More reliable, patient-specific intra-procedural estimation of the induced RFA ablation zones in the liver may lead to better planning of the safety margins around tumors. • Dedicated real-time simulation software to predict RFA-induced ablation zones in patients with liver malignancies has shown acceptable agreement with the follow-up results in a first prospective multicenter trial suggesting a randomized controlled clinical trial to evaluate potential outcome benefit for patients.

中文翻译：

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肝射频消融的计算机规划和实时模拟的临床评估（ClinicIMPPACT试用）。

目的评估一种全面的模拟工具，以计划和预测肝肿瘤中的射频消融（RFA）区域的准确性和临床可整合性。方法前瞻性多中心试验纳入了45例不同来源的51例恶性肝病灶患者。在接受CT引导的RFA之前，所有患者均接受了多期CT扫描，其中包括用于评估肝灌注的采集。这些数据用于生成肝脏的3D模型。RFA探针的术中位置由CT确定，并半自动注册到3D模型中。在RFA术后1个月，对比增强CT图像中模拟的消融区域的大小和形状与热消融区域的大小和形状进行了比较；将手术时间与历史对照组进行比较。结果模拟和分段消融区体积显示出显着的相关性（ρ= 0.59，p <0.0001），并且没有明显的偏差（Wilcoxon's Z = 0.68，p = 0.25）。消融区域比较的代表性指标如下：平均表面偏差（绝对平均误差，AAE）为3.4±1.7 mm，骰子相似系数为0.62±0.14，灵敏度为0.70±0.21，阳性预测值为0.66±0。 AAE与消融持续时间之间呈正相关（Δt； r = 0.37，p = 0.008）。调整Δt，肝灌注和先前的经动脉化学栓塞程序的个体间差异后，Δt是AAE的独立预测因子（ß= 0.03 mm / min，p = 0.01）。与历史对照组相比，模拟过程增加了3.5±1.9分钟。结论经过验证的仿真工具在预测肝RFA消融区域的大小和形状方面显示出可接受的速度和准确性。需要进一步的随机对照试验来评估该工具在多大程度上可以改善患者预后。要点•对肝脏中诱导的RFA消融区域进行更可靠，针对患者的过程内估计可能会导致更好地规划肿瘤周围的安全范围。•在第一个前瞻性多中心试验中，用于预测RFA诱导的肝恶性肿瘤患者消融区域的专用实时仿真软件已显示出可接受的一致性，该试验提示了一项随机对照临床试验，以评估对患者的潜在结局益处。