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

January 11, 2026 updated by: Xue Song, Guangdong Provincial Hospital of Traditional Chinese Medicine

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guanzhou, Guangdong, China, 510120
        • Guangdong Provincial Hospital of Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic nipple-sparing mastectomy (E-NSM) with immediate multistage fat grafting (IMFG)
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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
12months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 13, 2026

Primary Completion (Estimated)

January 13, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

January 11, 2026

First Submitted That Met QC Criteria

January 11, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 11, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZF202418003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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