Clinical trial NCT06569706: Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
Official title: Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Subcutaneous Mastectomy
Endoscopy
Breast reconstruction
Breast implants
Cancer patients
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 20
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients.
timeFrame: one day
Secondary outcomes:
measure: Operative time
timeFrame: one day
measure: Hospital stay
timeFrame: Through discharge from hospitalization, an average of 7 days
measure: Open surgery conversion rate
timeFrame: one day
measure: Oncologic safety of this approach
timeFrame: 1 and 2 years after surgery
measure: Concealed nature of the breast scar
timeFrame: Before surgery and 1 month and 3 months after surgery
measure: Number of participants with an infection
timeFrame: At surgery, and 1, 3, months after surgery
measure: Skin case necrosis
timeFrame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
measure: Complication rates (ischemia)
timeFrame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
measure: Number of participants with a local haematoma
timeFrame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
measure: Post-operative seromas
timeFrame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
measure: Necrosis of areolo-nipple plaque
timeFrame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
measure: Aesthetic result
timeFrame: 90 days and 1 year after surgery
measure: Life quality
timeFrame: Before surgery and 90 days and 1 year after surgery
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
References: