Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer (NEOMAMENDO)

University Hospital Center (CHU)

Status

Enrolling

Conditions

Breast Cancer

Treatments

Procedure: Nipple-Sparing Mastectomy, with immediate breast reconstruction

Study type

Interventional

Funder types

Other

Identifiers

NCT06569706

2024-A01008-39 (Other Identifier)

24_0132_UF7830

Details and patient eligibility

About

Nipple -Sparing Mastectomy (NSM), with immediate breast reconstruction (IBR) can be offered to patients requiring mastectomy when the lesion is more than 2cm from the nipple. Endoscopic mastectomy is a technical alternative for small-volume breasts (cup sizes A, B, C), offering a NSM with IBR, but also concealing the scar on the axillary line. It can be performed with traditional laparoscopic equipment, making this technique much more accessible and less costly than robotic mastectomy. It uses a single-port device that is significantly less costly than robotic equipment.

Feasibility and safety studies remain limited to the Asian continent, and it would undoubtedly be beneficial to initiate research in Europe to add this new technical option to our surgical arsenal. This study project aims to explore the feasibility and safety of endoscopic nipple-sparing mastectomy for breast cancer indications in a French center.

Full description

It s a practicability study, evaluating endoscopic approach for mastectomy, using an axillary single port in breast cancer patients. Conventional surgery conversion rate, operative time, infectious rate, esthetical outcomes, oncological safety and functional outcomes will be evaluated.

Enrollment

20 estimated patients

Sex

Female

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Women between 20 and 75 years.
Patient with an indication for curative mastectomy, either unilateral or bilateral, with nipple preservation:
- Extensive Carcinoma In Situ (CIS), more than 2 cm from the nipple
- Multicentric Infiltrating Carcinoma (IC), more than 2 cm from the nipple
- Large volume Infiltrating Carcinoma, more than 2 cm from the nipple
- IC or CIS for which the patient refuses conservative treatment, more than 2 cm from the nipple
Breast volumes: cup sizes A, B, or C as defined by underwear size, and glandular ptosis not exceeding grade 2 according to Regnault's classification
Patient wishing to undergo immediate breast reconstruction.
WHO/OMS (World Health Organization/Organisation Mondiale de la Santé) performance status <3

Exclusion criteria

Cutaneous carcinoma
Inflammatory breast
History of oncological breast surgery on the same breast
Patient who has received radiation treatment on the same breast
Breast hypertrophy requiring a nipple-bearing flap
Smoking ≥ 10 cigarettes/day
BMI > 35
Protected patient or unable to give consent according to Article L1121-8 of the French Public Health Code (CSP).
Patient participating in another interventional clinical study.
ASA (physical status score of the American Society of Anesthesiologists) >2.
Pregnant or breastfeeding women according to Article L1121-5 of the CSP.
Vulnerable persons (those receiving psychiatric care, those deprived of liberty, and those admitted to a health or social institution) according to Article L1121-6 of the CSP.
Absence of effective contraception for patients of childbearing age.
Absence of affiliation with a social security scheme.
Absence of collected free, informed, and written consent.