Department of General Surgery, Capital Medical University, Beijing, China.
Department of General Surgery, Capital Medical University Affiliated Beijing Friendship Hospital, Beijing, China.
BMJ Open. 2022 May 2;12(5):e047866. doi: 10.1136/bmjopen-2020-047866.
Breast cancer is the most prevalent cancer and the leading cause of cancer-related death in women. Conventional open mastectomy (C-OM) is one of the most common procedures for breast cancer, which involves the removal of the nipple-areola complex and a large proportion of the breast skin, leading to poor cosmetic effect and restriction of upper extremity function. Single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) could conceal the incision along the wrinkles in the axilla, preserve all the breast skin and nipple-areola complex and provide a better cosmetic outcome and quality of life. This trial aims to investigate the oncological safety between SIE-NSM and C-OM in early breast cancer patients.
This is a single centre, non-blinded, randomised controlled trial (RCT) and will be conducted at Beijing Friendship Hospital. Patients will be enrolled in the inpatient ward. Breast surgeons will notify patients who meet the inclusion and exclusion criteria with the instruction of this RCT. Patients will be randomly assigned to C-OM or SIE-NSM with a 3:1 allocation as per a computer-generated randomisation schedule. Patients will be followed-up for 12 months for analysing surgical outcomes. The primary outcome is the local recurrence rate at a 12-month follow-up. The secondary outcome is the distant metastasis rate, cosmetic satisfaction score and psychosocial well-being score after a 12-month follow-up. To ensure the accuracy of the cosmetic satisfaction score and psychosocial well-being score, the standard scale, Breast-Q score, will be applied.
This study will be conducted according to the medical ethics committee of the Beijing Friendship Hospital and according to the principles of the Declaration of Helsinki. All patients will receive clear instruction of their disease and treatment plan. Informed consent will be obtained from all patients when they agree to comply with our research plan. The results will be disseminated at academic presentations and publications in peer-reviewed journals. The raw data will be confidentially stored in our electronic data capture database. Data will not be shared unless an appropriate data request is submitted after the trial completion and peer-review journal publication.
NCT04461847.
乳腺癌是最常见的癌症，也是女性癌症相关死亡的主要原因。传统的开放式乳房切除术（C-OM）是治疗乳腺癌的最常见手术之一，它涉及切除乳晕复合体和大部分乳房皮肤，导致美容效果不佳和上肢功能受限。单孔充气内镜保乳术（SIE-NSM）可以隐藏沿着腋窝皱纹的切口，保留所有乳房皮肤和乳晕复合体，并提供更好的美容效果和生活质量。本试验旨在研究早期乳腺癌患者中 SIE-NSM 和 C-OM 之间的肿瘤学安全性。
这是一项单中心、非盲、随机对照试验（RCT），将在北京友谊医院进行。患者将在住院病房入组。乳腺外科医生将根据本 RCT 的说明通知符合纳入和排除标准的患者。患者将按照计算机生成的随机分组方案以 3:1 的比例随机分配到 C-OM 或 SIE-NSM 组。患者将在 12 个月时进行随访，以分析手术结果。主要结局是 12 个月随访时的局部复发率。次要结局是 12 个月随访时的远处转移率、美容满意度评分和心理社会健康评分。为了确保美容满意度评分和心理社会健康评分的准确性，将应用标准量表 Breast-Q 评分。
本研究将根据北京友谊医院医学伦理委员会和《赫尔辛基宣言》的原则进行。所有患者将收到关于其疾病和治疗计划的明确说明。所有患者在同意遵守我们的研究计划时将获得知情同意。结果将在学术会议上发表，并在同行评议期刊上发表。原始数据将在我们的电子数据捕获数据库中保密存储。除非在试验完成和同行评议期刊发表后提交适当的数据请求，否则不会共享数据。
NCT04461847。
