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...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-09-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2022.945123/full |
| _version_ | 1798000098385330176 |
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| author | Xiaobo Zhang Xiaobo Zhang Xiao Zhang Xiaoyi Ding Zhongmin Wang Yong Fan Guang Chen Xiaokun Hu Jiasheng Zheng Zhixiao Xue Xiaofeng He Xin Zhang Yingtian Wei Zhongliang Zhang Jing Li Jie Li Jie Yang Xiaodong Xue Li Ma Yueyong Xiao |
| author_facet | Xiaobo Zhang Xiaobo Zhang Xiao Zhang Xiaoyi Ding Zhongmin Wang Yong Fan Guang Chen Xiaokun Hu Jiasheng Zheng Zhixiao Xue Xiaofeng He Xin Zhang Yingtian Wei Zhongliang Zhang Jing Li Jie Li Jie Yang Xiaodong Xue Li Ma Yueyong Xiao |
| author_sort | Xiaobo Zhang |
| collection | DOAJ |
| 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 |
| first_indexed | 2024-04-11T11:14:49Z |
| format | Article |
| id | doaj.art-2f1febc5816e44aab4ca5cbc1d8a9103 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-11T11:14:49Z |
| publishDate | 2022-09-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-2f1febc5816e44aab4ca5cbc1d8a91032022-12-22T04:27:16ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-09-011210.3389/fonc.2022.945123945123Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical studyXiaobo Zhang0Xiaobo Zhang1Xiao Zhang2Xiaoyi Ding3Zhongmin Wang4Yong Fan5Guang Chen6Xiaokun Hu7Jiasheng Zheng8Zhixiao Xue9Xiaofeng He10Xin Zhang11Yingtian Wei12Zhongliang Zhang13Jing Li14Jie Li15Jie Yang16Xiaodong Xue17Li Ma18Yueyong Xiao19Department of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, ChinaChinese PLA Medical School, Beijing, ChinaDepartment of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, ChinaDepartment of Interventional Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Interventional Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, ChinaDepartment of Medical Imaging, Tianjin Medical University General Hospital, Tianjin, ChinaDepartment of Radiology, Tianjin First Central Hospital, Tianjin, ChinaDepartment of Interventional Radiology, Affiliated Hospital of Qingdao University, Qingdao, ChinaCenter of Interventional Oncology and Liver Diseases, Beijing Youan Hospital, Beijing, ChinaSchool of Biomedical Engineering and Technology, Tianjin Medical University, Tianjin, ChinaDepartment of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, ChinaDepartment of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, ChinaDepartment of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, ChinaDepartment of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, ChinaDepartment of Radiology, Characteristic Medical Center of Chinese People’s Armed Police Force, Tianjin, ChinaDepartment of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, ChinaDepartment of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, ChinaDepartment of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, China0Department of Anesthesiology, First Medical Center, Chinese People’s Liberation Army General Hospital, Beijing, ChinaDepartment of Radiology, First Medical Center, Chinese People's Liberation Army General Hospital, Beijing, ChinaIrreversible 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: ChiCTR1800017516https://www.frontiersin.org/articles/10.3389/fonc.2022.945123/fullirreversible electroporation-based ablation (IRE)ablationradiofrequencyliver cancerhepatocellular carcinoma |
| spellingShingle | Xiaobo Zhang Xiaobo Zhang Xiao Zhang Xiaoyi Ding Zhongmin Wang Yong Fan Guang Chen Xiaokun Hu Jiasheng Zheng Zhixiao Xue Xiaofeng He Xin Zhang Yingtian Wei Zhongliang Zhang Jing Li Jie Li Jie Yang Xiaodong Xue Li Ma Yueyong Xiao Novel irreversible electroporation ablation (Nano-knife) versus radiofrequency ablation for the treatment of solid liver tumors: a comparative, randomized, multicenter clinical study Frontiers in Oncology irreversible electroporation-based ablation (IRE) ablation radiofrequency liver cancer hepatocellular carcinoma |
| 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 | irreversible electroporation-based ablation (IRE) ablation radiofrequency liver cancer hepatocellular carcinoma |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2022.945123/full |
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