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计算机引导的肝射频消融治疗计划和实时模拟的临床评估(ClinicIMPPACT 试验)。

Clinical evaluation of in silico planning and real-time simulation of hepatic radiofrequency ablation (ClinicIMPPACT Trial).

机构信息

Department of Diagnostic and Interventional Radiology, University of Leipzig Medical Center, Liebigstraße 20, 04103, Leipzig, Germany.

Department of Interventional Radiology, Helios Park-Klinikum Leipzig, Leipzig, Germany.

出版信息

Eur Radiol. 2020 Feb;30(2):934-942. doi: 10.1007/s00330-019-06411-5. Epub 2019 Aug 30.

DOI:10.1007/s00330-019-06411-5
PMID:31471752
Abstract

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.

摘要

目的

评估一种全面的模拟工具在规划和预测肝肿瘤射频消融(RFA)区域方面的准确性和临床适用性。

方法

45 例 51 个不同来源的恶性肝肿瘤患者纳入前瞻性多中心研究。在 CT 引导下 RFA 前,所有患者均行多期 CT 检查,包括评估肝灌注的采集。这些数据用于生成肝脏的 3D 模型。RFA 探头的术中位置通过 CT 确定,并半自动地与 3D 模型配准。将模拟消融区域的大小和形状与 RFA 后 1 个月增强 CT 图像上分割的热消融区域进行比较;并将手术时间与历史对照组进行比较。

结果

模拟和分割的消融区域体积呈显著相关(ρ=0.59,p<0.0001),无显著偏差(Wilcoxon 的 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±1.7mm,Dice 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±0.07。AAE 与消融持续时间(∆t)之间存在中度正相关(r=0.37,p=0.008)。调整个体间∆t、肝灌注和先前经动脉化疗栓塞术的差异后,∆t 是 AAE 的独立预测因子(β=0.03mm/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

经过验证的模拟工具在预测肝 RFA 消融区域的大小和形状方面具有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的预后。

关键点

  1. 更可靠、个体化的术中肝 RFA 消融区域估计,可能导致更好地规划肿瘤周围的安全边界。

  2. 专门用于预测肝恶性肿瘤患者 RFA 诱导消融区域的实时模拟软件,在首次前瞻性多中心试验中与随访结果具有可接受的一致性,提示为评估患者潜在获益进行随机对照临床试验是合理的。

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Radiofrequency ablation versus surgical resection of hepatocellular carcinoma: contemporary treatment trends and outcomes from the United States National Cancer Database.射频消融与手术切除治疗肝细胞癌:来自美国国家癌症数据库的当代治疗趋势和结果。
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