NCT06569706

Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: Female
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Nipple-Sparing Mastectomy, with immediate breast reconstruction	It is an endoscopic approach for mastectomy using an axillary single port

Timeline

• Start date: 2024-10-18
• Primary completion: 2026-10-18
• Completion: 2029-10-18
• First posted: 2024-08-26
• Last updated: 2026-01-05

Locations

1 site across 1 country: France