Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer Non-invasive Breast Cancer; Breast Cancer Early Stage Breast Cancer (Stage 1-3); High Risk Breast Carcinoma
• Intervention / Treatment: Other: Video assisted mastectomy

• Study Type: Observational
• Enrollment (Estimated): 126

Contacts and Locations

• Study Contact: Name: Alejandra García Novoa, PhD MD; Phone Number: 296113 981178000; Email: maria.alejandra.garcia.novoa@sergas.es

Study Locations

• Spain
  • Galicia
    • A Coruña, Galicia, Spain, 15006
      • Recruiting
      • Breast Unit. First floor. Hospital Abente y Lago. Paseo del General Sir John Moore, 4
      • Principal Investigator: Benigno Acea Nebril, Ph.D
      • Contact: Alejandra García Novoa, Ph.D; Phone Number: 296158 0034981178000; Email: malejandagarcianovoa@gmail.com
      • Contact: Benigno Acea Nebril, Ph.D.; Phone Number: 296158 +34981178000; Email: benigno.acea.nebril@sergas.es
      • Principal Investigator: Alejandra García Novoa, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Video assisted mastectomy; Patients with a video-assisted nipple skin sparing mastectomy	Other: Video assisted mastectomy; Nipple Skin sparing mastectomy assisted by endoscopic or robotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant Loss	Safety of the reconstruction technique, calculated by the number of implants lost	First year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local relapse	evaluate oncological safety in terms of local relapses	first 5 years
Glandular residual tissue	Residual glandular tissue after endoscopic mastectomy identified by magnetic resonance imaging one year after the intervention	first year
Suvival	Overall survival	5 years

Collaborators and Investigators

• Sponsor: Alejandra García-Novoa

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2034

Study Registration Dates

• First Submitted: February 2, 2025
• First Submitted That Met QC Criteria: February 6, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 6, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: VideoBreast-24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No