Clinical trial NCT06995118: The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Keywords: Breast Cancer
Endoscopic surgery
Nipple-sparing mastectomy
Minimal invasive surgery
Lead sponsor: West China Hospital
Sponsor class: OTHER
Collaborators: name: West China Tianfu Hospital, Sichuan University
name: West China School of Public Health and West China Fourth Hospital, Sichuan University
name: The Fourth People's Hospital of Sichuan Province
name: The First Affiliated Hospital of Zhengzhou University
name: The First Hospital of Jilin University
name: Shanxi Bethune Hospital
name: Chengdu Fifth People's Hospital
name: Suzhou Municipal Hospital
name: Taiyuan Central Hospital of Shanxi Medical University
name: The People's Hospital of DAZU ，Chongqing
name: Anyang City Tumor Hospital
name: Mianyang Hospital of Traditional Chinese Medicine
name: Sichuan Cancer Hospital and Research Institute
name: Deyang People's Hospital
name: Hunan University of Traditional Chinese Medicine
name: The Affiliated Hospital of lnner Mongolia Medical University
name: Guangzhou First People's Hospital
name: Fujian Medical University Union Hospital
name: Nanchang People's Hospital
First posted: 2025-05-29
Enrollment: 337
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Operative time
timeFrame: Intraoperative
Secondary outcomes:
measure: Complications
timeFrame: Immediate postoperative, within 3-month postoperative, and within 1-year postoperative
measure: Aesthetic outcome evaluation--BREAST-Q scores
timeFrame: Preoperative (baseline), 3-month postoperative, and 2-year postoperative
measure: Aesthetic outcome evaluation--SCAR-Q score
timeFrame: 3-month postoperative and 2-year postoperative
measure: Aesthetic outcome evaluation--Ueda score
timeFrame: 3-month postoperative and 2-year postoperative
measure: Quality of Life--BREAST-Q scores
timeFrame: Preoperative (baseline), 3-month postoperative, and 2-year postoperative
measure: Surgical margin involvement
timeFrame: 2-3 weeks postoperative after paraffin-embedded pathological report available
measure: Resection mastectomy weight
timeFrame: Immediate postoperative
measure: Local Recurrence-Free Survival(LRFS)
timeFrame: 2-year postoperative and 5-year postoperative
measure: Disease-Free Survival(DFS)
timeFrame: 2-year postoperative and 5-year postoperative
measure: Overall Survival(OS)
timeFrame: 2-year postoperative and 5-year postoperative
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Anyang
country: China
facility: Anyang City Tumor Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: The First Hospital of Hunan University of Chinese Medicine
state: Hunan
city: Hohhot
country: China
facility: The Affiliated Hospital of lnner Mongolia Medical University
state: Inner Mongolia
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Nanchang
country: China
facility: Nanchang People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Taiyuan Central Hospital of Shanxi Medical University
state: Shanxi
city: Chengdu
country: China
facility: The Fourth People's Hospital of Sichuan Province
state: Sichuan
city: Chengdu
country: China
facility: Chengdu Fifth People's Hospital
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer Hospital
state: Sichuan
city: Chengdu
country: China
facility: West China hospital of Sichuan University
state: Sichuan
city: Chengdu
country: China
facility: West China School of Public Health and West China Fourth Hospital, Sichuan University
state: Sichuan
city: Deyang
country: China
facility: Deyang People's Hospital
state: Sichuan
city: Mianyang
country: China
facility: Mianyang Hospital of Traditional Chinese Medicine
state: Sichuan
city: Chongqing
country: China
facility: The People's Hospital of Dazu, Chongqing
Study officials:
References:
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