The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction: A National Multicenter, Open-Label, Randomized Controlled Trial (HUAXI-h-01)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 337
- 试验地点
- 20
- 主要终点
- Operative time
研究概览
简要总结
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.
详细描述
Conventional open nipple-sparing mastectomy (NSM) often results in significant surgical scarring, which is detrimental to the aesthetic outcome of the breast and the patient's psychosocial well-being. Meanwhile, endoscopic NSM has been reported to achieve favorable aesthetic outcomes and surgical safety. However, traditional endoscopic NSM has high technical difficulty and low surgical efficiency.
Our team has developed an innovative reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) following extensive research and clinical practice. This pioneering technique leverages the expansive force of gas to form a universal retractor. It employs an innovative reverse dissection sequence from deep to superficial layers, which retains the advantages of traditional endoscopic NSM while significantly improving operative efficiency. However, gland resection in the lower and inner quadrant of the breast remains technically challenging due to the long working distance and complex manipulation, often resulting in prolonged operative time and risks of incomplete gland resection.
To address these limitations, the West China Hospital team developed the "HUAXI Hole 1" technique-a 2-mm auxiliary incision at the superolateral edge of the areola, through which the electric scalpel is inserted to assist the gland resection. It can significantly reduce interference between instruments caused by the transaxillary single-incision approach and facilitate complete gland resection, which may contribute to improved surgical efficiency, surgical safety, and oncologic safety with the aesthetic advantages of the endoscopic technique. However, some researchers are concerned about the risks, such as nipple and areola complex (NAC) ischemia/necrosis, incision dehiscence, and surgical site infection. The prospective clinical evidence validating its efficacy and safety is currently lacking.
Therefore, this national multicenter, open-label, randomized controlled trial 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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;
- •Patients volunteered to provide informed consent.
排除标准
- •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);
- •Severe comorbidities precluding general anesthesia or surgery;
- •BMI ≥40 kg/m²;
- •HbA1c >7.5%;
- •Immunodeficiency;
- •Active smoking with ≥20 cigarettes per day
- •Patients with concurrent participation in conflicting clinical trials.
研究组 & 干预措施
HH-01 group
Use 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction
干预措施: HUAXI hole 1 (Procedure)
Control group
Don't use 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction
结局指标
主要结局
Operative time
时间窗: Immediate postoperative
Overall operation time (minute) from skin incision to complete closure of incision, including breast cancer operations, lymph node surgery, and breast reconstructions.
次要结局
- Disease-Free Survival(DFS)(2-year postoperative and 5-year postoperative)
- Overall Survival(OS)(2-year postoperative and 5-year postoperative)
- Complications(Immediate postoperative, within 3-month postoperative, and within 1-year postoperative)
- Aesthetic outcome evaluation--BREAST-Q scores(Preoperative (baseline), 3-month postoperative, and 2-year postoperative)
- Quality of Life--BREAST-Q scores(Preoperative (baseline), 3-month postoperative, and 2-year postoperative)
- Surgical margin involvement(2-3 weeks postoperative after paraffin-embedded pathological report available)
- Resection mastectomy weight(Immediate postoperative)
- Local Recurrence-Free Survival(LRFS)(2-year postoperative and 5-year postoperative)
- Aesthetic outcome evaluation--BREAST-Q scores(Preoperative (baseline), 3-month postoperative, and 2-year postoperative)
- Overall Survival(OS)(2-year postoperative and 5-year postoperative)
- Aesthetic outcome evaluation--Harris score(3-month postoperative and 2-year postoperative)
- Quality of Life--BREAST-Q scores(Preoperative (baseline), 3-month postoperative, and 2-year postoperative)
- Resection mastectomy weight(Immediate postoperative)
- Complications(Immediate postoperative, within 3-month postoperative, and within 1-year postoperative)
- Aesthetic outcome evaluation--Ueda score(3-month postoperative and 2-year postoperative)
- Surgical margin involvement(2-3 weeks postoperative after paraffin-embedded pathological report available)
- Local Recurrence-Free Survival(LRFS)(2-year postoperative and 5-year postoperative)
- Disease-Free Survival(DFS)(2-year postoperative and 5-year postoperative)
研究者
Du Zhenggui
Clinical Professor
West China Hospital