Actively Recruiting
Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
Led by University Hospital, Montpellier · Updated on 2026-01-05
20
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women between 20 and 75 years.
- Indication for curative mastectomy with nipple preservation for one of the following: extensive carcinoma in situ more than 2 cm from the nipple, multicentric infiltrating carcinoma more than 2 cm from the nipple, large volume infiltrating carcinoma more than 2 cm from the nipple, or infiltrating carcinoma or carcinoma in situ where the patient refuses conservative treatment, all more than 2 cm from the nipple.
- Breast volume cup size A, B, or C with glandular ptosis grade not exceeding 2 by Regnault's classification.
- Desire to undergo immediate breast reconstruction.
- WHO/OMS performance status less than 3.
You will not qualify if you...
- Cutaneous carcinoma.
- Inflammatory breast cancer.
- Prior oncological breast surgery on the same breast.
- Prior radiation treatment on the same breast.
- Breast hypertrophy requiring a nipple-bearing flap.
- Smoking 10 or more cigarettes per day.
- Body Mass Index greater than 35.
- Protected patient or unable to give consent according to French Public Health Code.
- Currently participating in another interventional clinical study.
- ASA physical status score greater than 2.
- Pregnant or breastfeeding women.
- Vulnerable persons receiving psychiatric care, deprived of liberty, or admitted to health or social institutions.
- Lack of effective contraception for patients of childbearing age.
- No affiliation with a social security scheme.
- No free, informed, and written consent collected.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Uhmontpellier
Montpellier, France, 34295
Actively Recruiting
Research Team
G
Gauthier Rathat, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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