Clinical trial NCT06823414: Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Official title: Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy and Inmediate Reconstruction With Prepectoral Implant. Prospective Study for the Evaluation of the Feasibility and Safety of the Technique, Quality of Life and Cosmetic Results
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Breast Cancer Non-invasive Breast Cancer
High Risk Breast Carcinoma
Lead sponsor: University Hospital A Coruña
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with breast cancer or high risk for breast cancer who need a mastectomy. The mastectomy will be skin and nipple preserving and will be performed with endoscopic assistance

Brief summary: Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.


Eligibility criteria: Inclusion Criteria:

* Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included.

Exclusion Criteria:

* Sarcomas of the breast.
* Benign breast tumors.
* Prepectoral reconstruction with expansion.
* Impossibility to preserve the skin.
* Need for reduction pattern
* Inability to perform an MRI during follow-up (obesity, claustrophobia, etc.).
* Inability to complete the BREAST-Q™ questionnaire due to the patient's cognitive alterations.
* Refusal of the patient to participate in the study.

Primary outcomes:
measure: Implant Loss
timeFrame: First year after surgery
Secondary outcomes:
measure: local relapse
timeFrame: first 5 years
measure: Glandular residual tissue
timeFrame: first year
measure: Suvival
timeFrame: 5 years
Other outcomes:
Locations:
city: A Coruña
country: Spain
facility: Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4
state: Galicia
Study officials:
References:
citation: 1. Acea-Nebril B, García-Novoa A, Cereijo-Garea C, Conde C, Bouzón A, Díaz C. Safety and Quality of Life in Women with Immediate Reconstruction with Polyurethane Implants after Neoadjuvant Chemotherapy: Outcomes from The Preq-20 Trial. Cancers 2023;15(4):1113. doi: 10.3390/cancers15041113. 2. Acea B, García A, García L, Díaz C, Bouzón A, Conde C. Immediate breast reconstruction by prepectoral polyurethane implant: Preliminary results of the prospective study PreQ-20. Cir Esp (Engl Ed) 2023;101(3):187-197. doi: 10.1016/j.cireng.2022.09.021. 3. Nakajima H, Sakaguchi K, Mizuta N, et al. Video-assisted total glandectomy and immediate reconstruction for breast cancer. Biomed Pharmacother 2002;56 Suppl 1:205s-8s. 4. Wei Ch, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast; 2019:46:144-156. doi: 10.1016/j.breast.2019.05.013. 5. Wei Ch, Lai HW. Evolution of minimal access breast surgery. Gland Surg 2019;8(6):784-793. doi: 10.21037/gs.2019.11.16. 6. Toesca A, Paradze N, Manconi A, Galimberti V, Intra M, Colleoni M et al. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast 2017; Feb:31:51-56. doi: 10.1016/j.breast.2016.10.009. 7. Rathat G, Herlin C, Bonnel C, Captier G, Duraes M. Endoscopic Nipple-Sparing Mastectomy with Immediate Prepectoral Implant-Based Reconstruction: A Case Report Am J Case Rep 2019;20:1812-1816. doi: 10.12659/AJCR.919669.