This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) with the "HUAXI Hole 1" versus without the "HUAXI Hole 1". The study aims to evaluate differences in operative efficiency, surgical safety, postoperative aesthetics, and oncological safety between the two groups.
Female patients aged 18-70 years (inclusive18 and 70 years);
Patients eligible for unilateral or bilateral reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction, with concurrent contralateral endoscopic augmentation mammoplasty permitted;
Patients with preoperative pathological confirmation of non-specialized breast cancer (e.g., ductal carcinoma in situ, invasive ductal carcinoma, invasive lobular carcinoma) or eligibility for prophylactic mastectomy;
For non-specialized breast cancer patients, preoperative tumor size ≤5 cm (post-neoadjuvant chemotherapy if applicable), and no clinical or imaging evidence of invasion to the nipple, skin, subcutaneous fat, chest wall (referring to the bony thorax and intercostal muscles, excluding the pectoralis major and minor muscles) or distant metastasis preoperatively;
History of open breast surgery within 1 year before this procedure (excluding minimally invasive vacuum-assisted biopsy);
Breast cancer diagnosed during pregnancy or lactation;
Subnipple-plane scarring with radiotherapy;
Metastatic breast cancer (M1);
Du Zhenggui
Lead sponsor
West China Hospital
Sponsor institution
West China Tianfu Hospital
Collaborator
West China Fourth Hospital
Collaborator
Fourth People's Hospital of Sichuan Province
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The First Hospital of Jilin University
Collaborator
Shanxi Bethune Hospital
Collaborator
Chengdu Fifth People's Hospital
Collaborator
Suzhou Municipal Hospital
Collaborator
Taiyuan Central Hospital of Shanxi Medical University
Collaborator
The People's Hospital of DAZU ，Chongqing
Collaborator
Anyang City Tumor Hospital
Collaborator
Mianyang Hospital of Traditional Chinese Medicine
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Deyang People's Hospital
Collaborator
Hunan University of Traditional Chinese Medicine
Collaborator
The Affiliated Hospital of Inner Mongolia Medical University
Collaborator
Guangzhou First People's Hospital
Collaborator
Fujian Medical University Union Hospital
Collaborator
Nanchang People's Hospital
Collaborator