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

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.

ClinicalTrials.gov IDNCT06995118

PhaseNA

Enrollment337

SponsorDu Zhenggui

Age18 Years – 70 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer Early Stage Breast Cancer (Stage 1-3)

About this study

Interventions

Procedure: HUAXI hole 1 — A small incision of 2mm is made at the junction of the upper outer edge of the areola and the skin, through which the scalpel is placed to assist in the resection of breast glands in reverse-sequence nipple-sparing mastectomy and direct-to-implant breast reconstruction.

Primary outcomes

Operative time (Immediate postoperative)

Eligibility information

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.

Study locations

Fujian Medical University Union Hospital, Fuzhou, Fujian 350000 China
Guangzhou First People's Hospital, Guangzhou, Guangdong 510000 China
Anyang City Tumor Hospital, Anyang, Henan 455000 China
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan 450000 China
The First Hospital of Hunan University of Chinese Medicine, Changsha, Hunan 410000 China
The Affiliated Hospital of lnner Mongolia Medical University, Hohhot, Inner Mongolia 010000 China
Suzhou Municipal Hospital, Suzhou, Jiangsu 215000 China
Nanchang People's Hospital, Nanchang, Jiangxi 330000 China
The First Hospital of Jilin University, Changchun, Jilin 130000 China
Shanxi Bethune Hospital, Taiyuan, Shanxi 030000 China

Showing 10 of 20 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-01.