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Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study
Irreversible electroporation (IRE) is a soft tissue ablation technique that uses short electrical fields which induce the death of target cells. To evaluate the safety and efficacy of an IRE-based device compared to regular radiofrequency ablation (RFA) of solid liver tumors, in this multicenter, ra...
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9557230/ https://www.ncbi.nlm.nih.gov/pubmed/36249062 http://dx.doi.org/10.3389/fonc.2022.945123 |
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author | Zhang, Xiaobo Zhang, Xiao Ding, Xiaoyi Wang, Zhongmin Fan, Yong Chen, Guang Hu, Xiaokun Zheng, Jiasheng Xue, Zhixiao He, Xiaofeng Zhang, Xin Wei, Yingtian Zhang, Zhongliang Li, Jing Li, Jie Yang, Jie Xue, Xiaodong Ma, Li Xiao, Yueyong |
author_facet | Zhang, Xiaobo Zhang, Xiao Ding, Xiaoyi Wang, Zhongmin Fan, Yong Chen, Guang Hu, Xiaokun Zheng, Jiasheng Xue, Zhixiao He, Xiaofeng Zhang, Xin Wei, Yingtian Zhang, Zhongliang Li, Jing Li, Jie Yang, Jie Xue, Xiaodong Ma, Li Xiao, Yueyong |
author_sort | Zhang, Xiaobo |
collection | PubMed |
description | Irreversible electroporation (IRE) is a soft tissue ablation technique that uses short electrical fields which induce the death of target cells. To evaluate the safety and efficacy of an IRE-based device compared to regular radiofrequency ablation (RFA) of solid liver tumors, in this multicenter, randomized, parallel-arm, non-inferiority study, 152 patients with malignant liver tumors were randomized into IRE (n = 78) and RFA (n = 74) groups. The primary endpoint was the success rate of tumor ablation; the secondary endpoints included the tumor ablation time, complications, tumor recurrence rates and treatment-related adverse events (TRAE). The success rate of tumor ablation using IRE was 94.9% and was non-inferior to the RFA group (96.0%) (P = 0.761). For the secondary endpoints, the average ablation time was 34.29 ± 30.38 min for the IRE group, which was significantly longer than for the RFA group (19.91 ± 16.08 min) (P < 0.001). The incidences of postoperative complications after 1 week (P = 1.000), 1 month (P = 0.610) and 3 months (P = 0.490) were not significantly different between the 2 groups. The recurrence rates of liver tumor at 1, 3 and 6 months after ablation were 0 (0.0%), 10 (13.9%) and 10 (13.3%) in the IRE group and 2.9%, 7.3% and 19.7% in the RFA control group (all P > 0.05), respectively. For safety assessments, 51 patients experienced 191 AEs (65.4%) in the IRE group, which was not different from the RFA group (73.0%, 54/184) (P = 0.646). In 7 IRE patients, 8 TRAEs (7.9%) occurred, the most common being edema of the limbs (mild grade) and fever (severe grade), while no TRAEs occurred in the RFA group. This study proved that the excellent safety and efficacy of IRE was non-inferior to the regular radiofrequency device in ablation performance for the treatment of solid liver tumors. Clinical trial registration: Chinese Clinical Trial Registry: ChiCTR1800017516 |
format | Online Article Text |
id | pubmed-9557230 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-95572302022-10-14 Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study Zhang, Xiaobo Zhang, Xiao Ding, Xiaoyi Wang, Zhongmin Fan, Yong Chen, Guang Hu, Xiaokun Zheng, Jiasheng Xue, Zhixiao He, Xiaofeng Zhang, Xin Wei, Yingtian Zhang, Zhongliang Li, Jing Li, Jie Yang, Jie Xue, Xiaodong Ma, Li Xiao, Yueyong Front Oncol Oncology Irreversible electroporation (IRE) is a soft tissue ablation technique that uses short electrical fields which induce the death of target cells. To evaluate the safety and efficacy of an IRE-based device compared to regular radiofrequency ablation (RFA) of solid liver tumors, in this multicenter, randomized, parallel-arm, non-inferiority study, 152 patients with malignant liver tumors were randomized into IRE (n = 78) and RFA (n = 74) groups. The primary endpoint was the success rate of tumor ablation; the secondary endpoints included the tumor ablation time, complications, tumor recurrence rates and treatment-related adverse events (TRAE). The success rate of tumor ablation using IRE was 94.9% and was non-inferior to the RFA group (96.0%) (P = 0.761). For the secondary endpoints, the average ablation time was 34.29 ± 30.38 min for the IRE group, which was significantly longer than for the RFA group (19.91 ± 16.08 min) (P < 0.001). The incidences of postoperative complications after 1 week (P = 1.000), 1 month (P = 0.610) and 3 months (P = 0.490) were not significantly different between the 2 groups. The recurrence rates of liver tumor at 1, 3 and 6 months after ablation were 0 (0.0%), 10 (13.9%) and 10 (13.3%) in the IRE group and 2.9%, 7.3% and 19.7% in the RFA control group (all P > 0.05), respectively. For safety assessments, 51 patients experienced 191 AEs (65.4%) in the IRE group, which was not different from the RFA group (73.0%, 54/184) (P = 0.646). In 7 IRE patients, 8 TRAEs (7.9%) occurred, the most common being edema of the limbs (mild grade) and fever (severe grade), while no TRAEs occurred in the RFA group. This study proved that the excellent safety and efficacy of IRE was non-inferior to the regular radiofrequency device in ablation performance for the treatment of solid liver tumors. Clinical trial registration: Chinese Clinical Trial Registry: ChiCTR1800017516 Frontiers Media S.A. 2022-09-29 /pmc/articles/PMC9557230/ /pubmed/36249062 http://dx.doi.org/10.3389/fonc.2022.945123 Text en Copyright © 2022 Zhang, Zhang, Ding, Wang, Fan, Chen, Hu, Zheng, Xue, He, Zhang, Wei, Zhang, Li, Li, Yang, Xue, Ma and Xiao https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Oncology Zhang, Xiaobo Zhang, Xiao Ding, Xiaoyi Wang, Zhongmin Fan, Yong Chen, Guang Hu, Xiaokun Zheng, Jiasheng Xue, Zhixiao He, Xiaofeng Zhang, Xin Wei, Yingtian Zhang, Zhongliang Li, Jing Li, Jie Yang, Jie Xue, Xiaodong Ma, Li Xiao, Yueyong Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study |
title | Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study |
title_full | Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study |
title_fullStr | Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study |
title_full_unstemmed | Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study |
title_short | Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study |
title_sort | novel irreversible electroporation ablation (nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study |
topic | Oncology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9557230/ https://www.ncbi.nlm.nih.gov/pubmed/36249062 http://dx.doi.org/10.3389/fonc.2022.945123 |
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