Clinical Trial

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

Enrolling by Invitation
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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.
Trial Details
NCT Number NCT07352137
Lead Sponsor Guangdong Provincial Hospital of Traditional Chinese Medicine
Conditions Breast Cancer, Breast Reconstruction
Enrollment 20 participants
Start Date 2026-01-13
Primary Completion 2027-01-13 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-01-20