Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ENROLLING BY INVITATION
NCT07352137
NA

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

Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-01-13

Completion Date

2027-06-30

Last Updated

2026-01-20

Healthy Volunteers

No

Interventions

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.

Locations (1)

Guangdong Provincial Hospital Of Chinese Medicine

Guanzhou, Guangdong, China