EVA - Endoscopic Video-Assisted Nipple-Sparing Mastectomy (E-NSM): A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety. The procedure will be carried out by a dedicated surgical team in which at least one operator holds certified laparoscopic surgical training issued by a recognized scientific society, ensuring appropriate technical expertise and adherence to surgical safety standards.
详细描述
This pilot study aims to prospectively document the technical feasibility and perioperative outcomes of E-NSM performed according to an established institutional protocol, including standardized perfusion assessment using indocyanine green (ICG) angiography and patient-reported outcomes using BREAST-Q questionnaire. Data generated from this study will support refinement of the institutional protocol and inform the design of future comparative or multicentre trials.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged ≥18 years
- •Candidates for nipple-sparing mastectomy (NSM) with immediate reconstruction
- •Histologically confirmed invasive carcinoma cT1N0, or carriers of pathogenic germline mutations undergoing prophylactic mastectomy
- •Breast size I-III and absence of significant glandular ptosis
- •Signed informed consent
排除标准
- •Inflammatory breast cancer
- •Locally advanced clinical stage (cT2-T4 or N+)
- •Ductal carcinoma in situ (DCIS) without invasive component
- •Previous radiotherapy to the affected breast
- •Locoregional recurrence
- •Clinical conditions contraindicating prosthetic reconstruction
- •Indication for skin-sparing (SSM) or skin-reducing mastectomy (SRM)
- •Ongoing or completed neoadjuvant chemotherapy before surgery
- •Refusal or inability to sign informed consent
- •Inability to complete scheduled follow-up