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The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction

RecruitingNAAges 18 Years - 70 YearsFemaleDu Zhenggui
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • HUAXI hole 1
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Where

20 sites
Fujian Medical University Union Hospital
Fuzhou, China
Guangzhou First People's Hospital
Guangzhou, China
Anyang City Tumor Hospital
Anyang, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
The First Hospital of Hunan University of Chinese Medicine
Changsha, China
The Affiliated Hospital of lnner Mongolia Medical University
Hohhot, China
Suzhou Municipal Hospital
Suzhou, China
Nanchang People's Hospital
Nanchang, China

…and 12 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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