Actively Recruiting
The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
Led by Du Zhenggui · Updated on 2025-07-02
337
Participants Needed
20
Research Sites
341 weeks
Total Duration
On this page
Sponsors
D
Du Zhenggui
Lead Sponsor
W
West China Tianfu Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18-70 years (inclusive)
- Eligible for unilateral or bilateral reverse-sequence endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction
- Preoperative pathological confirmation of non-specialized breast cancer or eligibility for prophylactic mastectomy
- Tumor size 4 cm for non-specialized breast cancer patients, with no evidence of invasion to nipple, skin, chest wall, or distant metastasis
- Volunteered to provide informed consent
You will not qualify if you...
- 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/m8
- HbA1c over 7.5%
- Immunodeficiency
- Active smoking with 20 or more cigarettes per day
- Concurrent participation in conflicting clinical trials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
Not Yet Recruiting
2
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
3
Anyang City Tumor Hospital
Anyang, Henan, China, 455000
Not Yet Recruiting
4
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
5
The First Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China, 410000
Not Yet Recruiting
6
The Affiliated Hospital of lnner Mongolia Medical University
Hohhot, Inner Mongolia, China, 010000
Not Yet Recruiting
7
Suzhou Municipal Hospital
Suzhou, Jiangsu, China, 215000
Not Yet Recruiting
8
Nanchang People's Hospital
Nanchang, Jiangxi, China, 330000
Not Yet Recruiting
9
The First Hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
10
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
11
Taiyuan Central Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
12
The Fourth People's Hospital of Sichuan Province
Chengdu, Sichuan, China, 610011
Not Yet Recruiting
13
Chengdu Fifth People's Hospital
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
14
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
15
West China hospital of Sichuan University
Chengdu, Sichuan, China, 610041
Actively Recruiting
16
West China School of Public Health and West China Fourth Hospital, Sichuan University
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
17
West China Tianfu Hospital
Chengdu, Sichuan, China, 610041
Not Yet Recruiting
18
Deyang People's Hospital
Deyang, Sichuan, China, 618000
Not Yet Recruiting
19
Mianyang Hospital of Traditional Chinese Medicine
Mianyang, Sichuan, China, 621000
Not Yet Recruiting
20
The People's Hospital of Dazu, Chongqing
Chongqing, China, 400000
Not Yet Recruiting
Research Team
Z
Zhenggui Du, MD
CONTACT
H
Hui Dai, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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