Status:
RECRUITING
The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
Lead Sponsor:
Du Zhenggui
Collaborating Sponsors:
West China Tianfu Hospital, Sichuan University
West China Fourth Hospital, Sichuan University
Conditions:
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Eligibility:
FEMALE
18-70 years
Phase:
NA
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-implan...
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....
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 17 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
337 Patients enrolled
Trial Details
Trial ID
NCT06995118
Start Date
June 17 2025
End Date
December 31 2031
Last Update
July 2 2025
Active Locations (20)
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1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
2
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510000
3
Anyang City Tumor Hospital
Anyang, Henan, China, 455000
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000