近日，南昌大学第一附属医院成功实施首例局麻下的“微纳刀”肝癌消融术，该手术由我院消化内镜中心陈幼祥主任带领团队实施。此手术是首次在消化内科由内科医生成功实施“微纳刀”电穿孔肿瘤消融治疗，标志着“微纳刀”技术在肿瘤微创消融领域又登上了一个新的台阶。
Recently, the First Affiliated Hospital of Nanchang University successfully performed the first liver cancer ablation using the "Wknife" technique under local anesthesia. The surgery was led by Director Chen Youxiang and his team from the hospital's Gastrointestinal Endoscopy Center. This is the first time that an internal medicine doctor has successfully performed "Wknife" pulsed electric fields tumor ablation treatment in the field of the digestive oncology department, marking a new milestone for the "Wknife" technology in the field of minimally invasive tumor ablation.
本次治疗患者为58岁女性，诊断：肝细胞肝癌，病灶位于肝左叶近包膜，病灶大小2.2cm×1.7cm，患者有血吸虫性肝硬化失代偿期及布加综合征多年，肝功能Child-Pugh评分B级7分。由于患者肝硬化程度较严重，肝功能偏差，外科切除手术风险较大；此病人的肝癌病灶位于肝包膜下、靠近体表，如果采用局麻下的射频和微波消融难度较大，经我院MDT讨论决定给患者进行具有非热选择性、对患者肝功能影响小等独特优势的“微纳刀”微创消融治疗。
The patient undergoing this treatment is a 58-year-old female diagnosed with hepatocellular carcinoma. The lesion is located near the liver capsule in the left lobe of the liver, with a size of 2.2cm × 1.7cm. The patient has had Schistosoma-associated liver cirrhosis and Budd-Chiari syndrome for many years, and her liver function was evaluated as Child-Pugh B7. Due to the severity of the patient's liver cirrhosis and, deviation in liver function, surgical resection was considered to carry a high risk; The patient's liver cancer lesion is located beneath the liver capsule and close to the body surface, making it difficult to perform local anesthesia-based radiofrequency and microwave ablation. Therefore, after consultation with the hospital's MDT, it was decided to use the "Wknife" technique for minimally invasive ablation therapy, which has the unique advantages of non-thermal selectivity and minimal impact on the patient's liver function.
整个手术过程中，患者行局部麻醉，在B超引导下使用“微纳刀”通过单针对病灶区进行消融；消融过程历时24分钟。术中患者处于清醒状态，无可见肌肉收缩，也无明显疼痛或不适的感觉；术后即刻超声显示消融区低密度回声，并已完全覆盖病灶区，邻近血管未见损伤；随后患者安全返回病房，术后一天行超声造影显示消融区无造影剂增强，病灶消融达到全覆盖，且术中术后生命体征平稳，也未发现任何不良反应。
During the entire surgical procedure, the patient received local anesthesia and the "Wknife" was used under ultrasound guidance to perform the targeted ablation on the lesion area using a needle; The ablation process lasted for 24 minutes. The patient was awake during the procedure, with no visible muscle contractions and no obvious pain or discomfort; Immediately after the surgery, ultrasound showed low-density echoes in the ablation area, which had completely covered the lesion area, and there was no damage to the adjacent blood vessels. The patient safety returned to the ward and the next day, contrast-enhanced ultrasound showed no enhancement in the ablation area, indicating that the lesion had been fully covered by the ablation. The patient's vital signs were stable during and after the surgery, and no adverse reactions were observed.
“微纳刀”技术原理为脉冲电场导致细胞不可逆电穿孔从而实现肿瘤组织杀伤，是一种非热选择性物理消融技术，可在实现消融肿瘤的同时保留肿瘤周围的重要管道结构（血管、胆管和神经）完整性、并且无热沉效应，可以彻底消融肿瘤细胞，可以用于其他冷热消融都无法进行的特殊部位肿瘤消融治疗，被誉为下一代的肿瘤消融技术。
The "Wknife" technology works on the principle of irreversible cell electroporation induced by pulsed electric fields, leading to the destruction of tumor tissue. It is a non-thermal, selective physical ablation technique that can achieve tumor ablation while preserving the integrity of important ductal structures (blood vessels, bile ducts, and nerves) around the tumor, without any thermal effects. It even can destroy tumor cells and is suitable for the ablation of tumors in special locations where other hot or cold methods are not feasible. It is considered the next generation of tumor ablation technology.
南昌大学一附院消化内科是江西省首个集“国家临床重点专科”、“医学领先学科”、“重点实验室”、“高水平工程技术中心”和“消化疾病和内镜疾病诊疗中心”于一体的临床医学优势学科。本次手术，在消化内科陈幼祥主任带领下，郭贵海主任、钟嘉玮医生等团队人员协助下，采用“微纳刀”以及单针消融技术，成功实施首例在B超引导下的“微纳刀”肝癌治疗，首次由消化内科医生来进行“微纳刀”消融治疗，证实了消化内科医生在局麻条件下通过B超引导下也可以采用“微纳刀”为肝癌患者提供安全、高效的非热选择消融治疗，这是一次内科肝癌临床实践的创新，或将改变肝癌微创治疗的模式和规范。
The Department of Gastroenterology at the First Affiliated Hospital of Nanchang University is the first clinical medical specialty in Jiangxi Province with advantages that integrates "National Clinical Key Specialty", " Outsanding Medical Discipline", "Key Laboratory", "High-level Engineering Technology Center", and " Diagnosis and Treatment Center for Digestive and Endoscopic Diseases". Under the leadership of Director Chen Youxiang, assisted by Director Guo Guihai, Dr. Zhong Jiawei, and other team members, the Department of Gastroenterology at the First Affiliated Hospital of Nanchang University successfully performed the first liver cancer treatment under ultrasound guidance, using the “Wknife” and single-needle ablation technology. It was the first time that gastroenterologists performed "Wknife" ablation treatment and confirmed that under local anesthesia and B-ultrasound guidance, gastroenterologists can provide safe and effective non-thermal ablation treatment for liver cancer patients using the "Wknife" technique. This innovative clinical practice in gastroenterology may change the mode and standards of minimally invasive treatment for liver cancer.
“微纳刀”技术由重庆大学姚陈果教授团队研发，姚陈果教授从2000年开始，便致力于肿瘤细胞电穿孔的研究，于2004年曾发表了本领域国际上首篇学术研究论文，从此引发了国内外科学家对脉冲电场在肿瘤治疗领域的研究热潮。此后20余年来，姚教授团队一直致力于推进脉冲电场肿瘤治疗系统的研发，先后推出了微秒脉冲电穿孔技术（传统IRE）、高频复合脉冲电场电穿孔技术（HF-IRE）等两代IRE技术。然而，由于前两代的IRE技术会引起患者的肌肉强烈收缩，在治疗过程中需给予患者肌松剂并配合气管麻醉，另外治疗中所有的电极需要多针平行布针，医生学习和拿握难度非常大。
The "Wknife" technique was developed by Professor Yao Chen-guo's team from Chongqing University. Professor Yao has been devoted to the research of electroporation for tumor cells since 2000 and published the first academic research paper in this field in 2004, which triggered a research wave about the pulse electric fields in the field of tumor treatment among scientists both domestically and internationally. For more than 20 years since then, Professor Yao's team has been committed to promoting the development of a pulse electric field tumor treatment system and has successively launched two generations of IRE technology, namely the microsecond pulse electric perforation technology (traditional IRE) and the high-frequency pulse electric field ablation technology (HF-IRE). However, the first two generations of IRE technology can cause strong muscle contractions in patients during treatment, requiring patients to be given muscle relaxants and assisted with tracheal anesthesia. In addition, all electrodes used in treatment need to be placed parallel to each other with multiple needles, making it very difficult for doctors to learn and master.
姚教授团队在前期两代技术研发的基础上，研发了国际最领先的第三代IRE技术—“微纳刀”，解决了现有IRE技术对麻醉要求高、肌肉收缩强、布针难、范围小等问题。本次手术成功说明以后“微纳刀”肝癌消融在内科B超引导下就可以完成，病人不需要冒着麻醉意外的风险，医生只要有B超引导就可以轻松完成治疗。
Professor Yao's team successfully developed the world-leading third-generation IRE technology, called "Wknife", based on the previous two generations of technology development. This technology can solve the problems of high anesthesia requirements, strong muscle contractions, difficult needle insertion, and limited ablation area in the existing IRE technology. The success of this surgery demonstrates that "Wknife" can be used to ablate liver cancer under the guidance of internal medicine B-ultrasound, and patients do not need to risk anesthesia accidents. Doctors can easily complete the treatment with the guidance of B-ultrasound.
“微纳刀”技术的产品转化由杭州维纳安可医疗科技有限责任公司承担。该企业目前已研发完成了脉冲电场医疗器械系列产品并已全面进入临床试验阶段。此前“微纳刀“已经在清华长庚医院进行了多例局麻下的特殊部位肝癌消融取得了成功，证明了微纳刀在肝癌消融上的无禁区优势。更为重要的是，维纳安可公司在IRE技术方面完成了一系列的核心专利布局，彻底打破了以往国产不可逆电穿孔设备只有外围专利，没有核心基础专利的被动局面，为本技术走出国门、走向世界，从而造福更多患者奠定了坚实基础。
The product commercialization of the "Wknife" technology is being undertaken by Hangzhou Winner-Onco Medical Technology Co., Ltd. The company has developed a series of pulse electric field medical devices and has entered the clinical trial stage. Previously, "Wknife" has achieved success in the ablation of special location liver cancer under local anesthesia at Tsinghua Chang Gung Hospital, proving its advantage of no forbidden zone in liver cancer ablation. More importantly, Winner-Onco has completed a series of core patent layouts in IRE technology, which completely breaks the passive situation where domestic irreversible electroporation equipment only has peripheral patents but no core basic patents. This has laid a solid foundation for this technology to go abroad, go to the world, and benefit more patients.
