Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Uhmontpellier
RECRUITING
Montpellier
Contact Information
Primary
Gauthier Rathat, MD
g-rathat@chu-montpellier.fr
467336532
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2029-10-18
Participants
Target number of participants: 20
Treatments
Experimental: Nipple-Sparing Mastectomy, with immediate breast reconstruction
20 patients female with breast cancer will have a Nipple-Sparing Mastectomy, with immediate breast reconstruction
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov