HUAXI Hole 1–assisted reverse‑sequence endoscopic nipple‑sparing mastectomy with immediate implant reconstruction

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)

This project will test whether adding a 2‑mm 'HUAXI Hole 1' near the areola makes reverse‑sequence endoscopic nipple‑sparing mastectomy with direct‑to‑implant reconstruction faster, safer, and more cosmetic for women with early‑stage breast cancer or undergoing prophylactic mastectomy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 337 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: West China Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 20 sites (Fuzhou, Fujian and 19 other locations)
• Trial ID: NCT06995118 on ClinicalTrials.gov

What this trial studies

This is a multicenter, open‑label, randomized controlled comparison of reverse‑sequence endoscopic nipple‑sparing mastectomy (R‑E‑NSM) with immediate implant reconstruction performed with versus without a 2‑mm auxiliary incision called the HUAXI Hole 1. The HUAXI Hole 1 is a small superolateral areolar incision that allows insertion of an electric scalpel to assist gland resection and reduce instrument interference during transaxillary single‑incision endoscopic surgery. The trial will compare operative efficiency (including operative time), surgical safety, postoperative cosmetic outcomes, and short‑term oncologic safety between the two groups. Procedures are being performed at several tertiary hospitals in China with standardized protocols and prospective follow‑up.

Who should consider this trial

Good fit: Women aged 18–70 who are candidates for unilateral or bilateral reverse‑sequence endoscopic nipple‑sparing mastectomy with immediate implant reconstruction (including prophylactic mastectomy and early‑stage breast cancer ≤5 cm without clinical nipple/skin/chest‑wall invasion) are ideal candidates.

Not a fit: Patients with clinical or imaging evidence of nipple, skin, chest‑wall or distant invasion, tumors larger than 5 cm, prior open breast surgery, or otherwise not suitable for an endoscopic approach are unlikely to benefit from this technique.

Why it matters

Potential benefit: If successful, the HUAXI Hole 1 technique could shorten operative time, reduce technical difficulty, lower complication risk, and improve cosmetic outcomes while maintaining oncologic safety.

How similar studies have performed: Previous reports of endoscopic nipple‑sparing mastectomy have shown favorable cosmetic and safety outcomes, but the HUAXI Hole 1 is a novel auxiliary‑incision modification that has not been widely tested in randomized multicenter trials.

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.

Where this trial is running

Fuzhou, Fujian and 19 other locations

• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (NOT_YET_RECRUITING)
• Guangzhou First People's Hospital — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Anyang City Tumor Hospital — Anyang, Henan, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• The First Hospital of Hunan University of Chinese Medicine — Changsha, Hunan, China (NOT_YET_RECRUITING)
• The Affiliated Hospital of lnner Mongolia Medical University — Hohhot, Inner Mongolia, China (NOT_YET_RECRUITING)
• Suzhou Municipal Hospital — Suzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Nanchang People's Hospital — Nanchang, Jiangxi, China (NOT_YET_RECRUITING)
• The First Hospital of Jilin University — Changchun, Jilin, China (NOT_YET_RECRUITING)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• Taiyuan Central Hospital of Shanxi Medical University — Taiyuan, Shanxi, China (NOT_YET_RECRUITING)
• The Fourth People's Hospital of Sichuan Province — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Chengdu Fifth People's Hospital — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Sichuan Cancer Hospital — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• West China hospital of Sichuan University — Chengdu, Sichuan, China (RECRUITING)
• West China School of Public Health and West China Fourth Hospital, Sichuan University — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• West China Tianfu Hospital — Chengdu, Sichuan, China (NOT_YET_RECRUITING)
• Deyang People's Hospital — Deyang, Sichuan, China (NOT_YET_RECRUITING)
• Mianyang Hospital of Traditional Chinese Medicine — Mianyang, Sichuan, China (NOT_YET_RECRUITING)
• The People's Hospital of Dazu, Chongqing — Chongqing, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Zhenggui Du, MD

Conditions: Breast Cancer Early Stage Breast Cancer, Breast Cancer, Endoscopic surgery, Nipple-sparing mastectomy, Minimal invasive surgery