Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer

NCT ID: NCT06569706

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-18
• Study Completion Date: 2029-10-18

Brief Summary

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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Nipple-Sparing Mastectomy, with immediate breast reconstruction

20 patients female with breast cancer will have a Nipple-Sparing Mastectomy, with immediate breast reconstruction

Group Type: EXPERIMENTAL

Nipple-Sparing Mastectomy, with immediate breast reconstruction

Intervention Type: PROCEDURE

It is an endoscopic approach for mastectomy using an axillary single port

Interventions

Nipple-Sparing Mastectomy, with immediate breast reconstruction

It is an endoscopic approach for mastectomy using an axillary single port

Intervention Type: PROCEDURE

Other Intervention Names

Endoscopic approach of nipple-sparing mastectomy, with immediate breast reconstruction

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Uhmontpellier

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Gauthier Rathat, MD

Role: CONTACT

g-rathat@chu-montpellier.fr

467336532 ext. +33

Facility Contacts

RATHAT GAUTHIER, MD

Role: primary

g-rathat@chu-montpellier.fr

467336421 ext. 33

DURAES Martha, MD

Role: backup

duraesmartha@gmail.com

631329158 ext. 33

Other Identifiers

24_0132_UF7830

Identifier Type: -

Identifier Source: org_study_id

2024-A01008-39

Identifier Type: OTHER

Identifier Source: secondary_id