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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• West China hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting
• 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

Study contacts

• Study coordinator: Zhenggui Du, MD
• Email: docduzg@163.com
• Phone: +86 13880768222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.