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NCT Number: NCT06569706

Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Nipple-Sparing Mastectomy, with immediate breast reconstruction

Procedure

It is an endoscopic approach for mastectomy using an axillary single port

Other names: Endoscopic approach of nipple-sparing mastectomy, with immediate breast reconstruction

Primary outcomes

  1. Success rate of endoscopic nipple sparing mastectomy (E-NSM) for breast cancer patients.

    Time frame: 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.

Secondary outcomes

  1. Operative time

    Time frame: one day

    Duration of the prophylactic mastectomy with immediate breast reconstruction

  2. Hospital stay

    Time frame: Through discharge from hospitalization, an average of 7 days

    The duration of hospitalization will be noted upon discharge from hospitalization

  3. Open surgery conversion rate

    Time frame: one day

    Number of patients with open surgery conversion

  4. Oncologic safety of this approach

    Time frame: 1 and 2 years after surgery

    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.

  5. Concealed nature of the breast scar

    Time frame: Before surgery and 1 month and 3 months after surgery

    Number of patients with no visible scars, picture taken bare chest front and side after the surgery

  6. Number of participants with an infection

    Time frame: At surgery, and 1, 3, months after surgery

    Number of participants with postoperative infection after the mastectomy, including cases requiring implant replacement or removal.

  7. Skin case necrosis

    Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery

    The presence of skin case necrosis will be noted during all the visits after the surgery. It's severe if > 25%

  8. Complication rates (ischemia)

    Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery

    Nipple-Areola-Complex (NAC) Ischemia: comparison with literature data on conventional surgery, including grading of ischemia

  9. Number of participants with a local haematoma

    Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery

    Number of participants with a local haematoma caused by the mastectomy with immediate breast reconstruction requiring surgical intervention.

  10. Post-operative seromas

    Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery

    Number of patients with seromas after the mastectomy

  11. Necrosis of areolo-nipple plaque

    Time frame: At surgery, and 1, 3, 6, 12, 18, and 24 months after surgery

    The presence of necrosis of areolo-nipple plaque will be noted during all the visits after the surgery.

  12. Aesthetic result

    Time frame: 90 days and 1 year after surgery

    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.

  13. Life quality

    Time frame: Before surgery and 90 days and 1 year after surgery

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Gauthier Rathat, MD

CONTACT

[email protected]

467336532 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: NEOMAMENDO

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Aug 26, 2024
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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