The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3)
- Registration Number
- NCT06995118
- Lead Sponsor
- Du Zhenggui
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 337
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Operative time Intraoperative Overall operation time (minute) from skin incision to complete closure of incision, including breast cancer operations, lymph node surgery, and breast reconstructions
- Secondary Outcome Measures
Name Time Method 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
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--SCAR-Q score 3-month postoperative and 2-year postoperative The APPEARANCE SCALE of the SCAR-Q questionnaire is employed to assess the patient-reported aesthetic outcomes of scars. Transformed scores range from 0 to 100, with higher values indicating better results. Both raw questionnaire scores and standardized transformed scores will be documented
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
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
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.
Trial Locations
- Locations (19)
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
Anyang City Tumor Hospital
🇨🇳Anyang, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The First Hospital of Hunan University of Chinese Medicine
🇨🇳Changsha, Hunan, China
The Affiliated Hospital of lnner Mongolia Medical University
🇨🇳Hohhot, Inner Mongolia, China
Suzhou Municipal Hospital
🇨🇳Suzhou, Jiangsu, China
Nanchang People's Hospital
🇨🇳Nanchang, Jiangxi, China
The First Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Taiyuan Central Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
The Fourth People's Hospital of Sichuan Province
🇨🇳Chengdu, Sichuan, China
Chengdu Fifth People's Hospital
🇨🇳Chengdu, Sichuan, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
West China hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
West China School of Public Health and West China Fourth Hospital, Sichuan University
🇨🇳Chengdu, Sichuan, China
Deyang People's Hospital
🇨🇳Deyang, Sichuan, China
Mianyang Hospital of Traditional Chinese Medicine
🇨🇳Mianyang, Sichuan, China
The People's Hospital of Dazu, Chongqing
🇨🇳Chongqing, China