纳秒脉冲电场消融作为高危部位肝细胞癌的一线根治性治疗：一项前瞻性多中心研究

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

作者信息

Xu Min, Zhang Wu, Xu Danxia, Dong Gang, Ren Zhigang, Aji Tuerganaili, Ji Jiansong, Zhao Qiyu, Pan Jinhua, Chen Xinhua, Jiang Tian'An

机构信息

Department of Ultrasound Medicine, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China.

Shulan (Hangzhou) Hospital Affiliated to Zhejiang Shuren University, Shulan International Medical College, Hangzhou, China.

出版信息

Int J Surg. 2025 May 1;111(5):3289-3298. doi: 10.1097/JS9.0000000000002361.

DOI:10.1097/JS9.0000000000002361

PMID:40146263

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12165518/

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.

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.

摘要

背景

临床前研究表明，纳秒级脉冲电场消融（nsPEF）是一种新型非热消融方式，可根除关键结构附近的肿瘤。我们开展了这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

本研究在中国的五家医院进行。纳入符合米兰标准且紧邻（<0.5 cm）门静脉、肝静脉、膈肌、胃肠道、肝包膜或胆囊的HCC患者。主要终点为1个月时的完全消融率及不良事件。次要终点包括局部肿瘤进展（LTP）、无复发生存期（RFS）和总生存期。

结果

2020年3月至至2022年6月，共纳入192例患者（148例男性[77.1%]；中位年龄58.5岁[四分位间距，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个肿瘤中有91.7%实现了完全消融。直径<2 cm的肿瘤1个月时的完全消融率显著高于直径≥2 cm的肿瘤（90.1%对71.7%，P = 0.002）。LTP的1年、2年和3年累积发生率估计分别为9.8%、13.8%和15.7%。最大肿瘤直径（风险比[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%。未观察到围手术期热损伤。9例（5.6%）患者发生≥3级治疗相关不良事件。