外科理论与实践 ›› 2024, Vol. 29 ›› Issue (05): 376-381.doi: 10.16139/j.1007-9610.2024.05.02
收稿日期:
2024-08-05
出版日期:
2024-09-25
发布日期:
2025-01-23
通讯作者:
陈洁,E-mail: chenjiewestchina@163.com作者简介:
*共同第一作者
ZHAO Xin, GAO Peng,*, CHEN Jie()
Received:
2024-08-05
Online:
2024-09-25
Published:
2025-01-23
摘要:
近年来,以腔镜技术和机器人手术系统为代表的微创外科技术成为外科治疗发展的新趋势。机器人手术具有精准、微创、美观等优势,在乳腺外科领域得到了越来越广泛应用。本文通过分析文献,综述了近年来机器人手术在乳腺癌治疗中的应用,包括技术的发展、手术的可行性、安全性等,为机器人手术系统在乳腺癌治疗中的应用提供理论依据。
中图分类号:
赵鑫, 高鹏, 陈洁. 机器人辅助手术系统在乳腺癌治疗中的应用及前景[J]. 外科理论与实践, 2024, 29(05): 376-381.
ZHAO Xin, GAO Peng, CHEN Jie. Robotic-assisted surgical systems in treatment of breast cancer: applications and prospects[J]. Journal of Surgery Concepts & Practice, 2024, 29(05): 376-381.
表1
来自Clinicaltrial.gov网站的有关机器人辅助乳腺手术的最新临床试验记录
Clinicaltrial.gov ID | 研究单位 | 研究类型 | 研究对象 | 主要研究终点 | 状态 | 研究题目 |
---|---|---|---|---|---|---|
NCT05945914 | Chang Gung Memorial Hospital | 前瞻性观察性研究 | 2020.3—2023.6同时接受机器人辅助乳房切除术和机器人辅助游离DIEP皮瓣采集术进行乳房重建的病人 | 急、慢性并发症发生率 | 已完成 | Oncoplastic entirely robot-assisted approach (opera) - incorporating robotic surgery in both mastectomy and DIEP flap reconstruction |
NCT04108117 | Severance Hospital | 多中心观察性研究 | 2016—2020年期间接受NSM的病人(共招募659例) | 术后 30 d内的并发症发生率 | 已完成 | Surgical and oncologic outcomes after RNSM and immediate reconstruction: an international multicenter pooled analysis |
NCT06415526 | Chang Gung Memorial Hospital | 回顾性观察性研究 | 接受机器人辅助乳房切除术和机器人辅助游离 DIEP皮瓣采集术行乳房重建的单侧乳腺癌病人(共招募14例) | 切口长度、手术时间、皮瓣大小 | 已完成 | Oncoplastic entirely robot-assisted approach (OPERA) - incorporating robotic surgery in both mastectomy and DIEP flap reconstruction |
NCT06532955 | Maastricht University Medical Center | 前瞻性干预性研究 | 60例接受机器人辅助或人工淋巴-静脉吻合术(LVA)治疗乳腺癌相关淋巴水肿(BCRL)的病人 | LVA的效率 | 进行中 | Pilot study on robotic assisted microsurgical lymphatico-venular anastomosis |
NCT04585074 | Severance Hospital | 前瞻性观察性研究 | 19~80岁乳腺癌或乳腺癌高风险(BRCA1/2、TP53、PALB2基因突变等),计划接受治疗性或预防性乳房切除术,并希望即刻乳房重建的病人 | 术后30 d内并发症发生率、Clavien-Dindo术后并发症分级 | 进行中 | Prospective cohort study of mastectomy with reconstruction including robot endoscopic breast surgery |
NCT05720039 | Intuitive Surgical (Responsible Party) | 前瞻性、双臂、多中心、随机对照临床研究 | ≥21岁的早期乳腺癌病人,接受da Vinci机器人辅助SP手术或开放乳头乳晕切除术 | da Vinci Xi机器人辅助手术转换为开放手术的比例、不良事件发生率、手术边缘阳性率 | 进行中 | A prospective, multicenter randomized controlled trial (RCT) of the Da Vinci® SP™ surgical system vs. open surgery in NSM procedures |
NCT02274493 | M.D. Anderson Cancer Center | 前瞻性干预性临床研究 | 年满18岁且正在接受需采集背阔肌的整形手术,同意接受术后6个月的随访 | 机器人辅助采集术后背阔肌瓣(latissimus dorsi, LD)存活的参与者人数、术后 6个月捐献部位并发症评估 | 已完成 | Pilot study of robotic-assisted harvest of the latissimus dorsi muscles |
NCT03440398 | European Institute of Oncology | 前瞻性随机临床研究 | 82例接受开放NSM和即刻假体植入乳房重建术或RNSM的病人 | 病人的满意度;术后效果,包括并发症、术后疼痛、长期肿瘤治疗效果等 | 进行中 | RNSM and immediate robotic breast reconstruction vs. conventional open technique: a prospective randomized trial evaluating patients satisfaction |
NCT05490433 | Yonsei University | 前瞻性多中心随机临床研究 | 19~70岁确诊为乳腺癌,接受RNSM或传统开放NSM的病人 | 5年无病生存率、5年总生存率、5年乳腺癌特异性生存率 | 进行中 | A Prospective Multicenter Rando-mized Clinical Trial: Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM) Trial |
NCT05448963 | Chang Gung Memorial Hospita | 前瞻性干预性临床研究 | 20~80岁乳腺癌病人或预防性乳房切除术候选者接受SP辅助单侧或双侧NSM | 手术效果(使用da Vinci SP系统完成NSM,未转换为传统腹腔镜、多孔da Vinci手术或开放手术的比例) | 进行中 | A pilot study of RNSM followed by immediate breast reconstruction using da Vinci SP ® single-port system |
NCT04151368 | University Health Network, Toronto | 前瞻性单臂干预性临床研究 | 患有浸润性乳腺癌、DCIS、BRCA或其他乳腺癌基因突变携带的任何年龄女性 | RNSM可行性、切口并发症、首次复发部位 | 已暂停 | Robotic NSM with immediate prosthetic breast reconstruction: prospective study of feasibility, safety and patient satisfaction, Toronto experience |
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