Journal of Surgery Concepts & Practice ›› 2024, Vol. 29 ›› Issue (05): 376-381.doi: 10.16139/j.1007-9610.2024.05.02
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ZHAO Xin, GAO Peng,*, CHEN Jie()
Received:
2024-08-05
Online:
2024-09-25
Published:
2025-01-23
Contact:
CHEN Jie
E-mail:chenjiewestchina@163.com
CLC Number:
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.
Tab 1
Recent robotic-assisted breast surgery clinical trial records from the Clinicaltrial.gov website
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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