Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Nipple-Sparing Mastectomy, with immediate breast reconstruction
  It is an endoscopic approach for mastectomy using an axillary single port

Первичные конечные точки

• Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients. [Срок оценки: one day]

Вторичные конечные точки (12)

• Operative time [Срок оценки: one day]
• Hospital stay [Срок оценки: Through discharge from hospitalization, an average of 7 days]
• Open surgery conversion rate [Срок оценки: one day]
• Oncologic safety of this approach [Срок оценки: 1 and 2 years after surgery]
• Concealed nature of the breast scar [Срок оценки: Before surgery and 1 month and 3 months after surgery]
• Number of participants with an infection [Срок оценки: At surgery, and 1, 3, months after surgery]
• Skin case necrosis [Срок оценки: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery]
• Complication rates (ischemia) [Срок оценки: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery]
• Number of participants with a local haematoma [Срок оценки: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery]
• Post-operative seromas [Срок оценки: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery]
• Necrosis of areolo-nipple plaque [Срок оценки: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery]
• Aesthetic result [Срок оценки: 90 days and 1 year after surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Uhmontpellier — Montpellier

Идентификаторы

NCT: NCT06569706 · 24_0132_UF7830 · 2024-A01008-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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