A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma
Abstract Background At present, the main clinical application of local ablation therapy, such as radiofrequency ablation (RFA), is to heat the tissue to a certain temperature. However, high temperature will cause thermal damage. Irreversible electroporation (IRE) is a novel minimally invasive local...
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BMC
2024-12-01
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| Series: | World Journal of Surgical Oncology |
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| Online Access: | https://doi.org/10.1186/s12957-024-03614-z |
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| author | Chao Cheng Min Xu Jinhua Pan Qiang Chen Kai Li Dong Xu Xiang Jing Qiang Lu Hong Yang Qiyu Zhao Zhuang Deng Tian’an Jiang |
| author_facet | Chao Cheng Min Xu Jinhua Pan Qiang Chen Kai Li Dong Xu Xiang Jing Qiang Lu Hong Yang Qiyu Zhao Zhuang Deng Tian’an Jiang |
| author_sort | Chao Cheng |
| collection | DOAJ |
| description | Abstract Background At present, the main clinical application of local ablation therapy, such as radiofrequency ablation (RFA), is to heat the tissue to a certain temperature. However, high temperature will cause thermal damage. Irreversible electroporation (IRE) is a novel minimally invasive local ablation technology for tumors. By high-frequency pulse, the tumor cell membrane can be irretrievably perforated, resulting in the destruction of the intracellular environment, which can preserve important structures in the treatment area. However, there are no randomized controlled clinical trials comparing the efficacy of IRE with traditional local ablation in the treatment of liver cancer. Aims This study aims to conduct a randomized controlled clinical trial comparing the efficacy of IRE with RFA in the treatment of liver cancer. Methods We will conduct a multicenter, randomized, parallel-controlled non-inferiority clinical trial to compare the efficacy and safety of IRE and RFA for hepatocellular carcinoma (HCC). One hundred and ninety patients with HCC from five academic medical centers will be enrolled. The patients will be randomized into treatment arm (IRE) and control arm (RFA). The primary outcome is the progress -free survival (PFS) and the key secondary outcome is the Overall survival (OS). Results Forty-eight patients had been recruited from 5 centers, of which, 33 patients (median age, 59.1 years) with 38 tumors had completed the 1-month follow-up and 21 patients have complete the 3-month follow up, with 2.3 months median follow up period. The mean largest tumor diameter is 3.9 cm. No end point was observed for PFS or OS in both groups, and the complete ablation rate was 100% in both groups. The lesions in the IRE group showed obvious shrinkage 1 month after procedure. One major adverse event (AE) was occurred in the control group. Conclusion This is the first randomized controlled clinical trial to compare the clinical effects of IRE and RFA. The preliminary results suggest that both RFA and IRE are effective in the treatment of HCC, which can provide strong evidence for the use of IRE in HCC and provide more options for the treatment of patients with HCC. Clinical Trial Registration ClinicalTrials. gov, identifier NCT05451160. |
| format | Article |
| id | doaj-art-9f9756e5fe6a4b2cb73a7349ef181916 |
| institution | Kabale University |
| issn | 1477-7819 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
| record_format | Article |
| series | World Journal of Surgical Oncology |
| spelling | doaj-art-9f9756e5fe6a4b2cb73a7349ef1819162024-12-22T12:29:31ZengBMCWorld Journal of Surgical Oncology1477-78192024-12-0122111110.1186/s12957-024-03614-zA multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinomaChao Cheng0Min Xu1Jinhua Pan2Qiang Chen3Kai Li4Dong Xu5Xiang Jing6Qiang Lu7Hong Yang8Qiyu Zhao9Zhuang Deng10Tian’an Jiang11Hepatobiliary and Pancreatic Intervention Center, The First Affiliated Hospital, Zhejiang University School of MedicineDepartment of Ultrasound Medicine, The First Affiliated Hospital, Zhejiang University School of MedicineDepartment of Ultrasound Medicine, The First Affiliated Hospital, Zhejiang University School of MedicineZhejiang CuraWay Medical Technology Co.,LtdDepartment of Ultrasound, The Third Affiliated Hospital of Sun Yat-sen UniversityZhejiang Cancer Hospital, Cancer Hospital of the University of Chinese Academy of SciencesDepartment of Ultrasound, Tianjin Third Central HospitalDepartment of Ultrasound, West China HospitalDepartment of Medical Ultrasonics, First Affiliated Hospital of Guangxi Medical UniversityDepartment of Ultrasound Medicine, The First Affiliated Hospital, Zhejiang University School of MedicineHepatobiliary and Pancreatic Intervention Center, The First Affiliated Hospital, Zhejiang University School of MedicineHepatobiliary and Pancreatic Intervention Center, The First Affiliated Hospital, Zhejiang University School of MedicineAbstract Background At present, the main clinical application of local ablation therapy, such as radiofrequency ablation (RFA), is to heat the tissue to a certain temperature. However, high temperature will cause thermal damage. Irreversible electroporation (IRE) is a novel minimally invasive local ablation technology for tumors. By high-frequency pulse, the tumor cell membrane can be irretrievably perforated, resulting in the destruction of the intracellular environment, which can preserve important structures in the treatment area. However, there are no randomized controlled clinical trials comparing the efficacy of IRE with traditional local ablation in the treatment of liver cancer. Aims This study aims to conduct a randomized controlled clinical trial comparing the efficacy of IRE with RFA in the treatment of liver cancer. Methods We will conduct a multicenter, randomized, parallel-controlled non-inferiority clinical trial to compare the efficacy and safety of IRE and RFA for hepatocellular carcinoma (HCC). One hundred and ninety patients with HCC from five academic medical centers will be enrolled. The patients will be randomized into treatment arm (IRE) and control arm (RFA). The primary outcome is the progress -free survival (PFS) and the key secondary outcome is the Overall survival (OS). Results Forty-eight patients had been recruited from 5 centers, of which, 33 patients (median age, 59.1 years) with 38 tumors had completed the 1-month follow-up and 21 patients have complete the 3-month follow up, with 2.3 months median follow up period. The mean largest tumor diameter is 3.9 cm. No end point was observed for PFS or OS in both groups, and the complete ablation rate was 100% in both groups. The lesions in the IRE group showed obvious shrinkage 1 month after procedure. One major adverse event (AE) was occurred in the control group. Conclusion This is the first randomized controlled clinical trial to compare the clinical effects of IRE and RFA. The preliminary results suggest that both RFA and IRE are effective in the treatment of HCC, which can provide strong evidence for the use of IRE in HCC and provide more options for the treatment of patients with HCC. Clinical Trial Registration ClinicalTrials. gov, identifier NCT05451160.https://doi.org/10.1186/s12957-024-03614-zIrreversible electroporation (IRE)Radiofrequency ablation (RFA)HCCAblationProtocol |
| spellingShingle | Chao Cheng Min Xu Jinhua Pan Qiang Chen Kai Li Dong Xu Xiang Jing Qiang Lu Hong Yang Qiyu Zhao Zhuang Deng Tian’an Jiang A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma World Journal of Surgical Oncology Irreversible electroporation (IRE) Radiofrequency ablation (RFA) HCC Ablation Protocol |
| title | A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma |
| title_full | A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma |
| title_fullStr | A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma |
| title_full_unstemmed | A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma |
| title_short | A multicenter, randomized, parallel-controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma |
| title_sort | multicenter randomized parallel controlled clinical trial protocol to evaluate the safety and efficacy of irreversible electroporation compared with radiofrequency ablation for the treatment of small hepatocellular carcinoma |
| topic | Irreversible electroporation (IRE) Radiofrequency ablation (RFA) HCC Ablation Protocol |
| url | https://doi.org/10.1186/s12957-024-03614-z |
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