Status:
RECRUITING
Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Breast Cancer
Eligibility:
FEMALE
20-75 years
Phase:
NA
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 ...
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 ra...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 18 2029
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06569706
Start Date
October 18 2024
End Date
October 18 2029
Last Update
January 5 2026
Active Locations (1)
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1
Uhmontpellier
Montpellier, France, 34295