Purpose

A consensus study of panelists was performed to provide a uniform protocol regarding (contra) indications, procedural parameters, perioperative care, and follow-up of irreversible electroporation (IRE) for the treatment of hepatic malignancies.

Materials and Methods

Interventional radiologists who had 2 or more publications on IRE, reporting at least 1 patient cohort in the field of hepatobiliary IRE, were recruited. The 8 panelists were asked to anonymously complete 3 iterative rounds of IRE-focused questionnaires to collect data according to a modified Delphi technique. Consensus was defined as having reached 80% or greater agreement.

Results

Panel members’ response rates were 88%, 75%, and 88% in rounds 1, 2, and 3, respectively; consensus was reached on 124 of 136 items (91%). Percutaneous or intraoperative hepatic IRE should be considered for unresectable primary and secondary malignancies that are truly unsuitable for thermal ablation because of proximity to critical structures. Absolute contraindications are ventricular arrhythmias, cardiac stimulation devices, and congestive heart failure of New York Heart Association class 3 or higher. A metal stent outside the ablation zone should not be considered a contraindication. For the only commercially available IRE device, the recommended settings are an inter-electrode distance of 10–20 mm and an exposure length of 20 mm. After 10 test pulses, 90 treatment pulses of 1500 V/cm should be delivered continuously, with a pulse length of 70–90 μs. The first post-procedural follow-up should take place 1 month after IRE and thereafter every 3 months, using cross-sectional imaging plus tumor marker assessment.

Conclusions

This article provides recommendations, created by a modified Delphi consensus study, regarding patient selection, workup, procedure, and follow-up of IRE treatment for hepatic malignancies.

中文翻译：

---

肝肿瘤的不可逆电穿孔：使用改良德尔菲技术的协议标准化

目的

进行了专门小组成员的共识研究，以提供关于（相反）适应症，手术参数，围手术期护理和不可逆电穿孔（IRE）治疗肝恶性肿瘤的统一协议。

材料和方法

招募了介入放射科医生，该放射放射科医生在IRE上发表了2篇或以上的论文，并报告了至少1例肝胆IRE领域的患者。根据改良的Delphi技术，要求8名小组成员匿名完成3轮以IRE为重点的调查问卷的迭代，以收集数据。共识定义为已达成80％或更高的共识。

结果

在第一，第二和第三轮中，小组成员的回应率分别为88％，75％和88％；在136个项目中有124个达成了共识（91％）。对于不可切除的原发性和继发性恶性肿瘤，应考虑经皮或术中肝IRE，这些恶性肿瘤由于靠近关键结构而确实不适合热消融。绝对禁忌症是室性心律失常，心脏刺激装置和纽约心脏协会3级或更高级别的充血性心力衰竭。消融区域外的金属支架不应视为禁忌症。对于唯一的商用IRE设备，建议的设置是电极间距离为10–20 mm，暴露长度为20 mm。经过10个测试脉冲后，应连续传送90个1500 V / cm的治疗脉冲，脉冲长度为70–90μs。首次手术后随访应在IRE后1个月进行，此后每3个月进行一次横截面成像加肿瘤标记物评估。

结论

本文提供了由改良的Delphi共识研究创建的有关患者选择，检查，程序以及IRE治疗肝恶性肿瘤的随访建议。