Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique

Breast Cancer Clinical Trial

Official title:

Robotic Nipple-Sparing Mastectomy And Immediate Robotic Breast Reconstruction Vs Conventional Open Technique: A Prospective Randomized Trial Evaluating Patients Satisfaction

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03440398
• Other study ID #: R 530/16- IEO 562
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 31, 2017
• Est. completion date: December 10, 2023

Study information

• Verified date: June 2023
• Source: European Institute of Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction

Description:

High proportion of patients with newly diagnosed early-stage breast cancer in Europe and US undergo to mastectomy. The absolute numbers of mastectomy rates in US is still today around 38% and represent one of the most performed operation for cancer reasons. Despite the lack of a natural cavity needed for endoscopic viewing, applications of robotic surgery have recently emerged for superficial organs such as in the fields of thyroidectomy, oropharyngeal surgery, plastic and reconstructive surgery. However, it has never been applied in breast cancer except for a feasibility and safety study conducted at European Institute of Oncology.

The technique was firstly published by Toesca et al. considering the first 3 cases. The same research as continued on breast cancer evaluating feasibility, reproducibility and safety studying 26 consecutive procedures of robotic nipple sparing mastectomy and immediate robotic breast reconstruction (article under peer to peer review at European Journal of Surgical Oncology, EJSO). In these initial cases of robotic nipple sparing mastectomy and immediate breast reconstruction authors found two main advantages such as the robotic optical vision and the minimal invasiveness. The two main limitations noticed in this initial experience were the duration of operating time and the additional costs related to the operation. The limitations of the applicability of robotic surgery to the breast, such as operating time and costs, might be offset by the advantages they observed such as better vision and minimally invasive approach with an anatomically more respectful mastectomy.

This project is a superiority trial comparing robotic nipple sparing mastectomy and immediate breast robotic reconstruction with conventional open technique.

The primary end-point is to evaluate patient satisfaction. Second end-point is to compare post-operative outcome considering complications, post-operative pain, reduction of the average length of stay of patients, long term oncological outcome of the two different surgical techniques.

Patients will be randomized into two treatment arms:

A. Open nipple-sparing mastectomy and immediate breast reconstruction with implant (Open NSM) B. Robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with implant (Robotic NSM) Both arms will undergo to the same pre-surgical staging, intra-operative axillary surgical staging, post-operative multidisciplinary evaluation and adjuvant treatments according to international and internal protocols.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 82
• Est. completion date: December 10, 2023
• Est. primary completion date: December 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Invasive breast cancer, Ductal Carcinoma In Situ, Breast Related Cancer Antigens mutation carriers.

• Any age

• Candidates to nipple-sparing mastectomy and immediate breast reconstruction

• Negative preoperative assessment of nipple-areola complex

• Absence of skin involvement

• Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section

• Breast volume = Bra IV; from cup A to D

• No hard smoking (hard smoking defined as >20 cigarettes/day)

• Low and intermediate risk for anesthesia (ASA Scale)

• Written informed consent must be signed and dated by the patient and the investigator prior to inclusion

• Patients must be accessible for follow-up

Exclusion criteria:

• Previous thoracic radiation therapy for any reason

• Inflammatory Breast Cancer

• Skin involvement

• Pre-operative diagnosis (radiological or cytological) of nipple-areola complex disease

• Pregnancy

• Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study

• Uncompensated Diabetes Mellitus

• Hard smokers (hard smoking defined as >20 cigarettes/day)

• High risk for anesthesia

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• Robotic NSM
Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction
• Open NSM
Open nipple-sparing mastectomy and immediate breast reconstruction with implant

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Toesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of — View Citation

Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;3 — View Citation

Toesca A, Peradze N, Manconi A, Nevola Teixeira LF. Reply to the letter to the editor "Robotic-assisted Nipple Sparing Mastectomy: A feasibility study on cadaveric models" by Sarfati B. et al. J Plast Reconstr Aesthet Surg. 2017 Apr;70(4):558-560. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction	The BREAST-Q survey is used to detect differences in patient satisfaction among the groups	1 year
Secondary	Average length of stay of patients	Reduction of the average length of stay of patients of the two different surgical techniques.	1 month
Secondary	Post operative complications	Compare post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)	1 month
Secondary	Cumulative incidence of local recurrence	Cumulative incidence of local recurrence	5 years
Secondary	Cumulative incidence of axillary recurrences	Cumulative incidence of axillary recurrences	5 years
Secondary	Cumulative incidence of distant recurrences	Cumulative incidence of distant recurrences	5 years
Secondary	Disease free survival	Disease free survival	5 years
Secondary	Overall survival	Overall survival	5 years

External Links

•   Article on "La Repubblica"
•   Interview to Dr Toesca