Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Conditions
Keywords
Breast Cancer, Endoscopic surgery, Nipple-sparing mastectomy, Minimal invasive surgery
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREHUAXI hole 1
A small incision of 2mm is made at the junction of the upper outer edge of the areola and the skin, through which the scalpel is placed to assist in the resection of breast glands in reverse-sequence nipple-sparing mastectomy and direct-to-implant breast reconstruction.
Sponsors
West China Tianfu Hospital, Sichuan University
West China Fourth Hospital, Sichuan University
The Fourth People's Hospital of Sichuan Province
The First Affiliated Hospital of Zhengzhou University
The First Hospital of Jilin University
Shanxi Bethune Hospital
Chengdu Fifth People's Hospital
Suzhou Municipal Hospital
Taiyuan Central Hospital of Shanxi Medical University
The People's Hospital of DAZU ，Chongqing
Anyang City Tumor Hospital
Mianyang Hospital of Traditional Chinese Medicine
Sichuan Cancer Hospital and Research Institute
Deyang People's Hospital
Hunan University of Traditional Chinese Medicine
The Affiliated Hospital of lnner Mongolia Medical University
Guangzhou First People's Hospital
Fujian Medical University Union Hospital
Nanchang People's Hospital
Du Zhenggui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Immediate postoperative | Overall operation time (minute) from skin incision to complete closure of incision, including breast cancer operations, lymph node surgery, and breast reconstructions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aesthetic outcome evaluation--BREAST-Q scores | Preoperative (baseline), 3-month postoperative, and 2-year postoperative | The Satisfaction with Breasts module of BREAST-Q questionnaire is utilized to assess patient-reported aesthetic outcomes. Transformed scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores |
| Aesthetic outcome evaluation--Harris score | 3-month postoperative and 2-year postoperative | The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted). |
| Aesthetic outcome evaluation--Ueda score | 3-month postoperative and 2-year postoperative | Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented |
| Quality of Life--BREAST-Q scores | Preoperative (baseline), 3-month postoperative, and 2-year postoperative | The Psychosocial Well-Being, Sexual Well-Being, and Physical Well-Being of the Chest modules of BREAST-Q questionnaire are used to evaluate quality of life (QoL) outcomes. Transformed scores range from 0 to 100, with higher values indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be recorded, along with pre- to postoperative differences in transformed scores |
| Complications | Immediate postoperative, within 3-month postoperative, and within 1-year postoperative | Skin flap thermal injury, skin flap ischemia/necrosis, nipple and areola complex(NAC) ischemia/necrosis, surgical site infection, incision dehiscence, surgical site bleeding or hematoma, seroma needing repeated aspiration or drain reinsertion, capsular contracture, prosthesis outline appearance, rippling, implant displacement, implant loss, readmission |
| Resection mastectomy weight | Immediate postoperative | Mean mastectomy weight (g) |
| Local Recurrence-Free Survival(LRFS) | 2-year postoperative and 5-year postoperative | The time interval from initiation of treatment to the first recurrence at the primary tumor site.If local recurrence appears, record the time and location of recurrence |
| Disease-Free Survival(DFS) | 2-year postoperative and 5-year postoperative | The period from treatment initiation to any disease recurrence (local, regional, or distant) or death.If above event appears, record the time and disease location. |
| Overall Survival(OS) | 2-year postoperative and 5-year postoperative | The time from treatment initiation (or diagnosis) to death from any cause. If death appears, record the time and reason. |
| Surgical margin involvement | 2-3 weeks postoperative after paraffin-embedded pathological report available | Surgical margin involvement was defined as ink on tumor on postoperative paraffin-embedded pathological examination |
Countries
China
Contacts
Primary ContactZhenggui Du, MD
Backup ContactHui Dai, MD
Outcome results
None listed