Endoscopic Nipple-Sparing Mastectomy (E-NSM) With Immediate Multistage Autologous Fat Grafting(IMAFG) for Total Breast Reconstruction Via the Axillary Incision

NCT07352137 | Enrolling By Invitation

• 1 other identifier: ZF202418003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to evaluate the effectiveness and safety of a novel breast reconstruction technique combining endoscopic nipple-sparing mastectomy (E-NSM) with immediate multistage fat grafting (IMFG) in female patients aged 18 years or older with clinical stage 0 to II breast cancer who desire immediate breast reconstruction. The main questions it aims to answer are: Does the combined E-NSM and IMFG approach improve patient-reported outcomes, including satisfaction with breasts and physical well-being, as measured by the BREAST-Q questionnaire? What is the frequency and nature of surgical complications associated with this technique, such as wound healing, hemorrhage, and need for reoperation? Participants will undergo endoscopic nipple-sparing mastectomy with lymph node surgery followed by immediate multistage fat grafting for total breast reconstruction via a small cosmetic axillary incision. They will also complete the BREAST-Q questionnaire and receive clinical and photography-based assessments at follow-up visits to evaluate aesthetic and quality-of-life outcomes.

Conditions

Breast Cancer; Breast Reconstruction

Keywords

Endoscopic; Nipple-Sparing Mastectomy; Fat Grafting; Breast Reconstruction

Outcome Measures

Primary Outcomes (2)

• Quality of life(QoL)

  QoL at 12 months after the final surgery. The BREAST-Q , version 2.0,22 which was used for measuring pre- and post reconstrucution, has several domains, 3 of which are evaluated for QOL.

  12 months

• The BREAST-Q score

  Quality of life at 12 months after the final surgery. The BREAST-Q , version 2.0,22 which was used for measuring pre- and post reconstrucution, has several domains, 3 of which are evaluated for QOL: psychosocial well-being, sexual well-being, physical well-being: chest

  12months

Study Arms (1)

Endoscopic nipple-sparing mastectomy (E-NSM) with immediate multistage fat grafting (IMFG)

EXPERIMENTAL

Patients with clinical stage 0 to II breast cancer underwent endoscopic nipple-sparing mastectomy (E-NSM) , lymph node surgery, and immediate multistage fat grafting (IMFG) reconstruction using a small cosmetic axillary incision for breast cancer treatment in a single Institution.

Procedure: endoscopic nipple-sparing mastectomy (E-NSM) with immediate implant-based reconstruction

Interventions

endoscopic nipple-sparing mastectomy (E-NSM) with immediate implant-based reconstruction PROCEDURE

The patient was positioned supine, with the operative-side arm wrapped and elevated to expose the axillary fossa endoscopically. After SLN excision and frozen-section analysis, the lateral edge of the pectoralis major was exposed. A sterile glove finger was used to sheath a wound retractor.Using the electrosurgical hook, the retromammary fat was dissected from the pectoralis major to a defined boundary, carefully preserving the serratus anterior fascia laterally and inferolaterally. Dissection then continued along the marked lateral margin. Subcutaneous breast dissection proceeded with Peng's dissector until the nipple base was transected and sent for frozen section.Fat was harvested via tumescent liposuction from the abdomen or thighs, manually centrifuged, and loaded into 10-mL syringes. It was then injected through the axillary incision into the intramuscular, intermuscular, and submuscular planes of the serratus anterior and pectoralis major muscles.

Endoscopic nipple-sparing mastectomy (E-NSM) with immediate multistage fat grafting (IMFG)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage 0-II( pTis,cT1-2N0-1M0）
• Candidate for a endoscopic nipple- sparing mastectomy procedure (multiple or extensive lesions)
• Patients' choice to undergo an immediate breast reconstruction
• Lack of serious comorbidities
• Accept standard adjuvant therapy

You may not qualify if:

• Breast cancer in pregnancy, tumours abutting the chest wall, skin (including inflammatory breast cancer), or nipple-areolar complex (NAC) (including Paget's disease), patients with breast cancer diagnosed as T3 or N2 and above, Allergic to lidocaine

Sponsors & Collaborators

• Guangdong Provincial Hospital of Traditional Chinese Medicine: lead

Study Sites (1)

Guangdong Provincial Hospital Of Chinese Medicine

Guanzhou, Guangdong, 510120, China

Location

Related Publications (4)

• 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). Ann Surg. 2024 Jan 1;279(1):138-146. doi: 10.1097/SLA.0000000000005924. Epub 2023 May 25.

  PMID: 37226826 RESULT

• 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 RESULT

• Narui K, Satake T, Ishikawa T, Muto M, Tsunoda Y, Yamada A, Kawashima K, Uenaka N, Fujiwara Y, Oshi M, Adachi S, Suzuki C, Wada T, Yamamoto S, Tanabe M, Maegawa J, Endo I. Endoscopic mastectomy followed by immediate breast reconstruction with fat grafting for breast cancer. Breast Cancer. 2024 May;31(3):476-484. doi: 10.1007/s12282-024-01561-x. Epub 2024 Mar 21.

  PMID: 38512534 RESULT

• Piatkowski AA, Wederfoort JLM, Hommes JE, Schop SSJ, Krastev TK, van Kuijk SMJ, van der Hulst RRWJ; Breast Reconstruction With External Preexpansion & Autologous Fat Transfer vs Standard Therapy (BREAST) Trial Investigators. Effect of Total Breast Reconstruction With Autologous Fat Transfer Using an Expansion Device vs Implants on Quality of Life Among Patients With Breast Cancer: A Randomized Clinical Trial. JAMA Surg. 2023 May 1;158(5):456-464. doi: 10.1001/jamasurg.2022.7625.

  PMID: 36857058 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guangdong Provincial Hospital of Traditional Chinese Medicine

Study Record Dates

• First Submitted: January 11, 2026
• First Posted: January 20, 2026
• Study Start: January 13, 2026
• Primary Completion (Estimated): January 13, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)