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

作者：Chao Cheng, Min Xu, Jinhua Pan, Qiang Chen, Kai Li, Dong Xu, Xiang Jing, Qiang Lu, Hong Yang, Qiyu Zhao, Zhuang Deng, Tianan Jiang · 发表于：World Journal of Surgical Oncology · 年份：2024 · DOI：10.1186/s12957-024-03614-z · 被引用次数：6 · 研究领域：Microbial Inactivation Methods、Hepatocellular Carcinoma Treatment and Prognosis、Silymarin and Mushroom Poisoning

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 com...