Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer

NCT06569706 | Recruiting DMC

• 2 other identifiers: 24_0132_UF78302024-A01008-39
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Subcutaneous Mastectomy; Endoscopy; Breast reconstruction; Breast implants; Cancer patients

Outcome Measures

Primary Outcomes (1)

• 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.

  one day

Secondary Outcomes (13)

• Operative time

  one day

• Hospital stay

  Through discharge from hospitalization, an average of 7 days

• Open surgery conversion rate

  one day

• 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

Study Arms (1)

Nipple-Sparing Mastectomy, with immediate breast reconstruction

EXPERIMENTAL

20 patients female with breast cancer will have a Nipple-Sparing Mastectomy, with immediate breast reconstruction

Procedure: Nipple-Sparing Mastectomy, with immediate breast reconstruction

Interventions

Nipple-Sparing Mastectomy, with immediate breast reconstruction PROCEDURE

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

Nipple-Sparing Mastectomy, with immediate breast reconstruction

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mastectomy, Subcutaneous

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Central Study Contacts

Gauthier Rathat, MD

CONTACT

467336532; g-rathat@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 26, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): October 18, 2026
• Study Completion (Estimated): October 18, 2029
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)