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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Reconstruction Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Guangdong Provincial Hospital Of Chinese Medicine

Guanzhou, Guangdong, 510120, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

• Age >18 years, female

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

Quality of life(QoL)

Time frame: 12 months

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.
The BREAST-Q score

Time frame: 12months

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

Sponsors and collaborators

Lead sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Other

Registry information

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jan 20, 2026
Registry last updated: Jan 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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