Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer

Last updated: October 28, 2024
Sponsor: University Hospital, Montpellier
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Nipple-Sparing Mastectomy, with immediate breast reconstruction

Clinical Study ID

NCT06569706
24_0132_UF7830
2024-A01008-39
  • Ages 20-75
  • Female

Study 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.

Eligibility Criteria

Inclusion

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 cmfrom the nipple

  • Breast volumes: cup sizes A, B, or C as defined by underwear size, and glandularptosis 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) performancestatus <3

Exclusion

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 theFrench 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, andthose admitted to a health or social institution) according to Article L1121-6 ofthe 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.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Nipple-Sparing Mastectomy, with immediate breast reconstruction
Phase:
Study Start date:
October 18, 2024
Estimated Completion Date:
October 18, 2029

Study 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.

Connect with a study center

  • Uhmontpellier

    Montpellier, 34295
    France

    Active - Recruiting

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