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

Guangdong Provincial Hospital of Traditional Chinese Medicine

Status: Invitation-only

Conditions: Breast Reconstruction; Breast Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07352137

ZF202418003

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

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