Endoscopic mastectomy for breast cancer patients
Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
This study is testing a new way to perform nipple-sparing mastectomy with immediate breast reconstruction for women with small to medium breasts and breast cancer to see if it is safe and effective while leaving less scarring.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 20 Years to 75 Years |
| Sex | Female |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Montpellier) |
| Trial ID | NCT06569706 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility and safety of endoscopic nipple-sparing mastectomy with immediate breast reconstruction for breast cancer patients. It focuses on women with small to medium breast sizes who require mastectomy due to specific cancer indications. The approach utilizes a single-port device to minimize scarring and reduce costs compared to robotic techniques. The study will assess various outcomes including operative time, infection rates, aesthetic results, and oncological safety.
Who should consider this trial
Good fit: Ideal candidates are women aged 20 to 75 with breast cancer indications for mastectomy and cup sizes A, B, or C.
Not a fit: Patients with inflammatory breast cancer, cutaneous carcinoma, or those who have had prior oncological surgery on the same breast may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could provide a less invasive surgical option with improved cosmetic outcomes for breast cancer patients.
How similar studies have performed: Feasibility and safety studies of similar endoscopic approaches have been limited to Asia, making this research novel for Europe.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Montpellier
- Uhmontpellier — Montpellier, France (Recruiting)
Study contacts
- Study coordinator: Gauthier Rathat, MD
- Email: g-rathat@chu-montpellier.fr
- Phone: 467336532
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.