An interventional study of Nipple-Sparing Mastectomy, with immediate breast reconstruction in Breast Cancer, sponsored by University Hospital, Montpellier. Recruiting at 1 site in France. Open to female participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-05.
Sponsored by University Hospital, Montpellier · Not applicable, Interventional, and Treatment
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.
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 20 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.
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Patient with an indication for curative mastectomy, either unilateral or bilateral, with nipple preservation:
Exclusion Criteria:
20 patients female with breast cancer will have a Nipple-Sparing Mastectomy, with immediate breast reconstruction
Procedure: Nipple-Sparing Mastectomy, with immediate breast reconstruction
It is an endoscopic approach for mastectomy using an axillary single port
Also known as: Endoscopic approach of nipple-sparing mastectomy, with immediate breast reconstruction
Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients.
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.
Time frame: one day
Operative time
Duration of the prophylactic mastectomy with immediate breast reconstruction
Time frame: one day
Hospital stay
The duration of hospitalization will be noted upon discharge from hospitalization
Time frame: Through discharge from hospitalization, an average of 7 days
Open surgery conversion rate
Number of patients with open surgery conversion
Time frame: one day
Oncologic safety of this approach
Evaluation of the early local recurrence of breast cancer rate at 1 and 2 year by imaging (breast ultrasound and/or MRI) and clinical examination. Recurrence will be defined by an attenuating tissue mass on ultrasound and/or suspicious contrast on MRI and/or a clinically palpable nodule, that will be confirmed by biopsy with histological analysis.
Time frame: 1 and 2 years after surgery
Concealed nature of the breast scar
Number of patients with no visible scars, picture taken bare chest front and side after the surgery
Time frame: Before surgery and 1 month and 3 months after surgery
Number of participants with an infection
Number of participants with postoperative infection after the mastectomy, including cases requiring implant replacement or removal.
Time frame: At surgery, and 1, 3, months after surgery
Skin case necrosis
The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if \> 25%
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Complication rates (ischemia)
Nipple-Areola-Complex (NAC) Ischemia: comparison with literature data on conventional surgery, including grading of ischemia
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Number of participants with a local haematoma
Number of participants with a local haematoma caused by the mastectomy with immediate breast reconstruction requiring surgical intervention.
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Post-operative seromas
Number of patients with seromas after the mastectomy
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Necrosis of areolo-nipple plaque
The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.
Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery
Aesthetic result
BREAST-Q© questionnaire Version 1.0 measure the quality of life and satisfaction among patients undergoing breast surgery. This questionnaire includes 6 modules: 1) Augmentation module, 2) Reduction/Mastectomy module, 3) Breast cancer: a) Mastectomy module, b) Reconstruction module, c) Breast reconstruction expectations module, d) Breast conserving therapy module. The conceptual framework of the modules is comprised of following two overarching themes (or domains): 1) Health-related quality of life and 2) Patient satisfaction. 1) Under each of these domains, there are six subthemes; Quality of life: 1) Psychosocial, 2) Physical and 3) Sexual well-being; and Patient satisfaction: 4) Satisfaction with Breasts, 5) Satisfaction with Outcome and 6) Satisfaction with care. Cf. https://qportfolio.org/wp-content/uploads/2023/01/BREAST-Q-BREAST-CANCER-USER-GUIDE.pdf for the response options.
Time frame: 90 days and 1 year after surgery
Life quality
Quality of life with an european quality of life scale (EQ-5D-5L). The EQ-5D-5L descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, few problems, some problems, severe problems and extreme problems. Rated level can be coded as a number 1, 2, 3, 4 or 5, which indicates having no problems for 1, having few problems for 2, some problems for 3, severe problems for 4, and having extreme problems for 5. As a result, a person's health status can be defined by a 5-digit number, ranging from 11111 (having no problems in all dimensions) to 55555 (having extreme problems in all dimensions).
Time frame: Before surgery and 90 days and 1 year after surgery
Plan to share: No
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University Hospital, Montpellier