Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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) >
- •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.
研究组 & 干预措施
Nipple-Sparing Mastectomy, with immediate breast reconstruction
20 patients female with breast cancer will have a Nipple-Sparing Mastectomy, with immediate breast reconstruction
干预措施: Nipple-Sparing Mastectomy, with immediate breast reconstruction (Procedure)
结局指标
主要结局
Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients.
时间窗: one day
The E-NSM is done by a scar in the axillary area, away from the breast, using single port endoscopy, with Implant base reconstruction in pre pectoral position. \- Complete excision of the gland by means of an incision on the axillary line, installation of a definitive smooth prosthesis, absence of conversion to a conventional approach.
次要结局
- Operative time(one day)
- Hospital stay(Through discharge from hospitalization, an average of 7 days)
- Number of participants with an infection(At surgery, and 1, 3, months after surgery)
- Open surgery conversion rate(one day)
- Skin case necrosis(At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery)
- Post-operative seromas(At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery)
- Necrosis of areolo-nipple plaque(At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery)
- Aesthetic result(90 days and 1 year after surgery)
- Oncologic safety of this approach(1 and 2 years after surgery)
- Concealed nature of the breast scar(Before surgery and 1 month and 3 months after surgery)
- Complication rates (ischemia)(At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery)
- Number of participants with a local haematoma(At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery)
- Life quality(Before surgery and 90 days and 1 year after surgery)