EndoBreast Study - Assessment of Feasibility, Functional Outcomes, and Sensitivity of the Areola-Nipple Complex in Endoscopic Mastectomy

Conditions studied

Breast Cancer, Breast Reconstruction

About this study

Study Design Prospective, single-center, observational, non-interventional study conducted in routine clinical practice. No investigational treatments or modifications to standard diagnostic, therapeutic, or follow-up procedures are planned. Consecutive eligible patients undergoing endoscopic nipple-sparing mastectomy (NSM) with immediate breast reconstruction will be prospectively enrolled. Background and Rationale Nipple-sparing mastectomy with immediate reconstruction is an established treatment for selected patients with breast cancer and women undergoing prophylactic mastectomy because of hereditary risk. Preservation of the nipple-areola complex (NAC) improves cosmetic outcomes, body image, and patient satisfaction while maintaining oncological safety. Endoscopic NSM is a minimally invasive alternative that may reduce scarring, surgical trauma, and recovery time while improving aesthetic outcomes without compromising oncological radicality. However, evidence remains limited, particularly in Europe, regarding feasibility, perioperative safety, sensory recovery, quality of life, reconstructive outcomes, and long-term oncological results. This study aims to prospectively collect real-world data from a consecutive cohort treated at a specialized breast center. Primary Objective To evaluate the feasibility and surgical safety of endoscopic NSM with immediate breast reconstruction in patients undergoing prophylactic or therapeutic mastectomy. Secondary Objectives To evaluate NAC sensory recovery at 6 and 12 months; assess oncological safety through surgical radicality and follow-up; evaluate quality of life and patient satisfaction using validated questionnaires; describe disease-free survival (DFS), overall survival (OS), reconstructive and aesthetic outcomes; and assess postoperative hospital stay. Primary Endpoints Overall incidence of early surgical complications; incidence of NAC necrosis, skin flap necrosis, infection, seroma, hematoma, hospital readmission, reoperation, and implant loss; recovery of NAC sensation at 6 and 12 months; and pathological assessment of retroareolar margin status. Secondary Endpoints BREAST-Q scores; local, regional, and distant recurrence; DFS; OS; and reconstructive/aesthetic outcomes. Study Population and Sample Size Thirty consecutive adult women undergoing prophylactic or therapeutic NSM with immediate implant-based reconstruction according to multidisciplinary evaluation. Main Inclusion Criteria Female; age…

Interventions

• Procedure: endoscopic mastectomy — Endoscopic NSM through a lateral inframammary incision using a combined open/endoscopic dissection. Intraoperative retroareolar frozen section and axillary staging (sentinel lymph node biopsy or axillary dissection) will be performed when indicated. Immediate prepectoral implant-based reconstruction will follow.

Primary outcomes

• Overall incidence of early surgical complications (adverse events in the first 90 days)
• recovery of NAC sensation (6-12 months)
• pathological assessment of retroareolar margin status (1 month)

Eligibility information

Study locations

• Ospedale degli Infermi ASL BI, Ponderano, BI 13875 Italy