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

Official title

The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction: A National Multicenter, Open-Label, Randomized Controlled Trial (HUAXI-h-01)

Overview

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.

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. Meanwhile, endoscopic NSM has been reported to achieve favorable aesthetic outcomes and surgical safety. However, traditional endoscopic NSM has high technical difficulty and low surgical efficiency.

Our team has developed an innovative reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction (DIBR) following extensive research and clinical practice. This pioneering technique leverages the expansive force of gas to form a universal retractor. It employs an innovative reverse dissection sequence from deep to superficial layers, which retains the advantages of traditional endoscopic NSM while significantly improving operative efficiency. However, gland resection in the lower and inner quadrant of the breast remains technically challenging due to the long working distance and complex manipulation, often resulting in prolonged operative time and risks of incomplete gland resection.

To address these limitations, the West China Hospital team developed the "HUAXI Hole 1" technique-a 2-mm auxiliary incision at the superolateral edge of the areola, through which the electric scalpel is inserted to assist the gland resection. It can significantly reduce interference between instruments caused by the transaxillary single-incision approach and facilitate complete gland resection, which may contribute to improved surgical efficiency, surgical safety, and oncologic safety with the aesthetic advantages of the endoscopic technique. However, some researchers are concerned about the risks, such as nipple and areola complex (NAC) ischemia/necrosis, incision dehiscence, and surgical site infection. The prospective clinical evidence validating its efficacy and safety is currently lacking.

Therefore, this national multicenter, open-label, randomized controlled trial 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.

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 outcome measures

• Operative time [Time frame: Immediate postoperative]

Secondary outcome measures (10)

• Complications [Time frame: Immediate postoperative, within 3-month postoperative, and within 1-year postoperative]
• Aesthetic outcome evaluation--BREAST-Q scores [Time frame: Preoperative (baseline), 3-month postoperative, and 2-year postoperative]
• Aesthetic outcome evaluation--Harris score [Time frame: 3-month postoperative and 2-year postoperative]
• Aesthetic outcome evaluation--Ueda score [Time frame: 3-month postoperative and 2-year postoperative]
• Quality of Life--BREAST-Q scores [Time frame: Preoperative (baseline), 3-month postoperative, and 2-year postoperative]
• Surgical margin involvement [Time frame: 2-3 weeks postoperative after paraffin-embedded pathological report available]
• Resection mastectomy weight [Time frame: Immediate postoperative]
• Local Recurrence-Free Survival(LRFS) [Time frame: 2-year postoperative and 5-year postoperative]
• Disease-Free Survival(DFS) [Time frame: 2-year postoperative and 5-year postoperative]
• Overall Survival(OS) [Time frame: 2-year postoperative and 5-year postoperative]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 20 centers

• Fujian Medical University Union Hospital — Fuzhou
• Guangzhou First People's Hospital — Guangzhou
• Anyang City Tumor Hospital — Anyang
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• The First Hospital of Hunan University of Chinese Medicine — Changsha
• The Affiliated Hospital of lnner Mongolia Medical University — Hohhot
• Suzhou Municipal Hospital — Suzhou
• Nanchang People's Hospital — Nanchang
• … and 12 more centers

Publications

• 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 11967683
• Yang 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 37422354
• Lai 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 29484564
• Zhou 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 38348883
• Qiu 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 38334846
• Feng 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 37991082
• Lai 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). PMID 37226826
• Kim 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 39141399

Identifiers

NCT: NCT06995118 · 2024(2591)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗