Nanosecond pulsed electric field ablation as first-line curative therapy for hepatocellular carcinoma in high-risk locations a prospective multicenter.

IF 12.5 2区 医学 Q1 SURGERY
Min Xu, Wu Zhang, Danxia Xu, Gang Dong, Zhigang Ren, Tuerganaili Aji, Jiansong Ji, Qiyu Zhao, Jinhua Pan, Xinhua Chen, Tian'An Jiang
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引用次数: 0

Abstract

Background: Preclinical studies have shown that nanosecond pulsed electric field ablation (nsPEF) is a novel nonthermal ablation modality that can eradicate tumors near critical structures. We conducted the prospective multicenter trial to investigate the efficacy and safety of nsPEF for hepatocellular carcinoma (HCC) in high-risk locations.

Materials and methods: This study was conducted at five hospitals in China. Patients with HCC fulfilling the Milan criteria and located immediately adjacent to (<0.5 cm) the portal vein, hepatic vein, diaphragm, gastrointestinal tract, liver capsule, or gallbladder were enrolled. The primary endpoint was the complete ablation rate at 1 month, and adverse events. The secondary endpoints included local tumor progression (LTP), recurrence-free survival (RFS), and overall survival (OS).

Results: From March, 2020, to June, 2022, 192 patients were enrolled (148 males [77.1%]; median age 58.5 years [interquartile range, 51.0-66.0 years]. The median follow-up duration was 33.5 months. The technical success rate was 99.5%. Complete ablation was achieved in 91.7% of the 217 tumors. Complete ablation rates at 1 month were significantly higher in tumors < 2 cm vs. ≥ 2 cm (90.1% vs. 71.7%, p = 0.002). The estimated 1-, 2- and 3-year cumulative incidences of LTP were 9.8%, 13.8%, and 15.7%, respectively. The maximum tumor diameter [hazard ratio (HR) = 2.62, p = 0.014] and age (HR = 0.42, p = 0.026) were independent predictive factors for LTP. The RFS rates at 1-, 2- and 3-year were 72.2%, 51.7%, and 43.5%, respectively. No periprocedural thermal damage was observed. Grade ≥ 3 treatment-related adverse events occurred in nine (5.6%) patients.

Conclusion: To our knowledge, this was the first prospective trial demonstrating that nsPEF was effective and relatively safe for HCC in high-risk locations, and may serve as an alternative therapeutic option for HCC suboptimal for thermal ablation.

纳秒脉冲电场消融作为高危部位肝细胞癌的一线治疗方法是一项前瞻性多中心研究。
临床前研究表明,纳秒脉冲电场消融(nsPEF)是一种新型的非热消融方式,可以消除关键结构附近的肿瘤。我们进行了一项前瞻性多中心试验,以研究nsPEF治疗高危部位肝细胞癌(HCC)的疗效和安全性。材料与方法:本研究在中国五家医院进行。结果:2020年3月至2022年6月,共纳入192例患者,其中男性148例,占77.1%;中位年龄58.5岁[四分位数间51.0-66.0岁]。中位随访时间为33.5个月。技术成功率为99.5%。217例肿瘤中有91.7%完全消融。肿瘤< 2 cm和≥2 cm患者1个月的完全消融率显著高于前者(90.1%比71.7%,p = 0.002)。估计1年、2年和3年LTP的累积发病率分别为9.8%、13.8%和15.7%。最大肿瘤直径[危险比(HR) = 2.62, p = 0.014]和年龄(HR = 0.42, p = 0.026)是LTP的独立预测因素。1年、2年和3年的RFS率分别为72.2%、51.7%和43.5%。术中未见热损伤。9例(5.6%)患者发生≥3级治疗相关不良事件。结论:据我们所知,这是首个证明nsPEF对高危部位HCC有效且相对安全的前瞻性试验,可以作为热消融不理想的HCC的替代治疗选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
17.70
自引率
3.30%
发文量
0
审稿时长
6-12 weeks
期刊介绍: The International Journal of Surgery (IJS) has a broad scope, encompassing all surgical specialties. Its primary objective is to facilitate the exchange of crucial ideas and lines of thought between and across these specialties.By doing so, the journal aims to counter the growing trend of increasing sub-specialization, which can result in "tunnel-vision" and the isolation of significant surgical advancements within specific specialties.
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