The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
HUAXI-h-01
1 other identifier
interventional
337
1 country
20
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-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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2025
Longer than P75 for not_applicable
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 7, 2025
CompletedFirst Posted
Study publicly available on registry
May 29, 2025
CompletedStudy Start
First participant enrolled
June 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2031
July 2, 2025
June 1, 2025
12 months
May 7, 2025
June 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Operative time
Overall operation time (minute) from skin incision to complete closure of incision, including breast cancer operations, lymph node surgery, and breast reconstructions.
Immediate postoperative
Secondary Outcomes (10)
Complications
Immediate postoperative, within 3-month postoperative, and within 1-year postoperative
Aesthetic outcome evaluation--BREAST-Q scores
Preoperative (baseline), 3-month postoperative, and 2-year postoperative
Aesthetic outcome evaluation--Harris score
3-month postoperative and 2-year postoperative
Aesthetic outcome evaluation--Ueda score
3-month postoperative and 2-year postoperative
Quality of Life--BREAST-Q scores
Preoperative (baseline), 3-month postoperative, and 2-year postoperative
- +5 more secondary outcomes
Study Arms (2)
HH-01 group
EXPERIMENTALUse 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction
Control group
NO INTERVENTIONDon't use 'HUAXI hole 1' to assist in reverse-sequence endoscopic nipple-sparing mastectomy combined with direct-to-implant breast reconstruction
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Du Zhengguilead
- West China Tianfu Hospital, Sichuan Universitycollaborator
- West China Fourth Hospital, Sichuan Universitycollaborator
- The Fourth People's Hospital of Sichuan Provincecollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- The First Hospital of Jilin Universitycollaborator
- Shanxi Bethune Hospitalcollaborator
- Chengdu Fifth People's Hospitalcollaborator
- Suzhou Municipal Hospitalcollaborator
- Taiyuan Central Hospital of Shanxi Medical Universitycollaborator
- The People's Hospital of DAZU ，Chongqingcollaborator
- Anyang City Tumor Hospitalcollaborator
- Mianyang Hospital of Traditional Chinese Medicinecollaborator
- Sichuan Cancer Hospital and Research Institutecollaborator
- Deyang People's Hospitalcollaborator
- Hunan University of Traditional Chinese Medicinecollaborator
- The Affiliated Hospital of lnner Mongolia Medical Universitycollaborator
- Guangzhou First People's Hospitalcollaborator
- Fujian Medical University Union Hospitalcollaborator
- Nanchang People's Hospitalcollaborator
Study Sites (20)
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
Taiyuan Central Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030000, China
The Fourth People's Hospital of Sichuan Province
Chengdu, Sichuan, 610011, China
Chengdu Fifth People's Hospital
Chengdu, Sichuan, 610041, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
West China hospital of Sichuan University
Chengdu, Sichuan, 610041, China
West China School of Public Health and West China Fourth Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
West China Tianfu Hospital
Chengdu, Sichuan, 610041, China
Deyang People's Hospital
Deyang, Sichuan, 618000, China
Mianyang Hospital of Traditional Chinese Medicine
Mianyang, Sichuan, 621000, China
The People's Hospital of Dazu, Chongqing
Chongqing, 400000, China
Related Publications (8)
Ho WS, Ying SY, Chan AC. Endoscopic-assisted subcutaneous mastectomy and axillary dissection with immediate mammary prosthesis reconstruction for early breast cancer. Surg Endosc. 2002 Feb;16(2):302-6. doi: 10.1007/s004640000203. Epub 2001 Nov 16.
PMID: 11967683BACKGROUNDYang H, Liang F, Xie Y, Qiu M, Du Z. Single axillary incision reverse-order endoscopic nipple/skin-sparing mastectomy followed by subpectoral implant-based breast reconstruction: Technique, clinical outcomes, and aesthetic results from 88 preliminary procedures. Surgery. 2023 Sep;174(3):464-472. doi: 10.1016/j.surg.2023.05.037. Epub 2023 Jul 7.
PMID: 37422354BACKGROUNDLai HW, Lin SL, Chen ST, Kuok KM, Chen SL, Lin YL, Chen DR, Kuo SJ. Single-Axillary-Incision Endoscopic-Assisted Hybrid Technique for Nipple-Sparing Mastectomy: Technique, Preliminary Results, and Patient-Reported Cosmetic Outcome from Preliminary 50 Procedures. Ann Surg Oncol. 2018 May;25(5):1340-1349. doi: 10.1245/s10434-018-6383-z. Epub 2018 Feb 26.
PMID: 29484564BACKGROUNDZhou J, Xie Y, Liang F, Feng Y, Yang H, Qiu M, Zhang Q, Chung K, Dai H, Liu Y, Liang P, Du Z. A novel technique of reverse-sequence endoscopic nipple-sparing mastectomy with direct-to-implant breast reconstruction: medium-term oncological safety outcomes and feasibility of 24-h discharge for breast cancer patients. Int J Surg. 2024 Apr 1;110(4):2243-2252. doi: 10.1097/JS9.0000000000001134.
PMID: 38348883BACKGROUNDQiu M, Liang F, Xie Y, Yang H, Zhang Q, Zhong J, Dai H, Du Z. Clinical Outcomes of Transaxillary Reverse-Sequence Endoscopic Nipple-Sparing Mastectomy and Direct-to-Implant Prepectoral Breast Reconstruction: A Prospective Study of Initial 68 Procedures. Ann Surg Oncol. 2024 Apr;31(4):2777-2785. doi: 10.1245/s10434-023-14687-7. Epub 2024 Feb 9.
PMID: 38334846BACKGROUNDFeng Y, Xie Y, Liang F, Zhou J, Yang H, Qiu M, Zhang Q, Liu Y, Liang P, Du Z. Twenty-four-hour discharge of patients after endoscopic nipple-sparing mastectomy and direct-to-implant breast reconstruction: safety and aesthetic outcomes from a prospective cohort study. Br J Surg. 2024 Jan 3;111(1):znad356. doi: 10.1093/bjs/znad356. No abstract available.
PMID: 37991082BACKGROUNDLai HW, Chen DR, Liu LC, Chen ST, Kuo YL, Lin SL, Wu YC, Huang TC, Hung CS, Lin YJ, Tseng HS, Mok CW, Cheng FT. Robotic Versus Conventional or Endoscopic-assisted Nipple-sparing Mastectomy and Immediate Prosthesis Breast Reconstruction in the Management of Breast Cancer: A Prospectively Designed Multicenter Trial Comparing Clinical Outcomes, Medical Cost, and Patient-reported Outcomes (RCENSM-P). Ann Surg. 2024 Jan 1;279(1):138-146. doi: 10.1097/SLA.0000000000005924. Epub 2023 May 25.
PMID: 37226826BACKGROUNDKim JH, Ryu JM, Bae SJ, Ko BS, Choi JE, Kim KS, Cha C, Choi YJ, Lee HY, Nam SE, Kim Z, Kang YJ, Lee MH, Lee JE, Park E, Shin HJ, Kim MK, Choi HJ, Kwon SU, Son NH, Park HS, Lee J; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group. Minimal Access vs Conventional Nipple-Sparing Mastectomy. JAMA Surg. 2024 Oct 1;159(10):1177-1186. doi: 10.1001/jamasurg.2024.2977.
PMID: 39141399BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
May 7, 2025
First Posted
May 29, 2025
Study Start
June 17, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 31, 2031
Last Updated
July 2, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- After publication of relevant research outputs, such as academic papers and books.
- Access Criteria
- When a request has been approved, the investigator will provide access to the de-identified individual patient-level data in the data management platform (Electronic Data Capture, EDC). A signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing the requested information. Additionally, all users will need to accept the terms and conditions of the data management platform to gain access.
Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.