Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03440398
Recruitment Status : Active, not recruiting
First Posted : February 21, 2018
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
European Institute of Oncology

Brief 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

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Robotic NSM Procedure: Open NSM Not Applicable

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robotic Nipple-Sparing Mastectomy And Immediate Robotic Breast Reconstruction Vs Conventional Open Technique: A Prospective Randomized Trial Evaluating Patients Satisfaction
Actual Study Start Date : March 10, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Open NSM
Conventional Nipple Sparing Mastectomy
Procedure: Open NSM
Open nipple-sparing mastectomy and immediate breast reconstruction with implant

Experimental: Robotic NSM
Robotic Nipple-Sparing Mastectomy
Procedure: Robotic NSM
Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction




Primary Outcome Measures :
  1. Patient satisfaction [ Time Frame: 1 year ]
    The BREAST-Q survey is used to detect differences in patient satisfaction among the groups


Secondary Outcome Measures :
  1. Average length of stay of patients [ Time Frame: 1 month ]
    Reduction of the average length of stay of patients of the two different surgical techniques.

  2. Post operative complications [ Time Frame: 1 month ]
    Compare post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)

  3. Cumulative incidence of local recurrence [ Time Frame: 5 years ]
    Cumulative incidence of local recurrence

  4. Cumulative incidence of axillary recurrences [ Time Frame: 5 years ]
    Cumulative incidence of axillary recurrences

  5. Cumulative incidence of distant recurrences [ Time Frame: 5 years ]
    Cumulative incidence of distant recurrences

  6. Disease free survival [ Time Frame: 5 years ]
    Disease free survival

  7. Overall survival [ Time Frame: 5 years ]
    Overall survival



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03440398


Locations
Layout table for location information
Italy
European Institute of Oncology
Milan, Italy, 20145
Sponsors and Collaborators
European Institute of Oncology
Investigators
Layout table for investigator information
Principal Investigator: Antonio Toesca, MD European Institute of Oncology

Additional Information:
Publications of Results:
Layout table for additonal information
Responsible Party: European Institute of Oncology
ClinicalTrials.gov Identifier: NCT03440398     History of Changes
Other Study ID Numbers: R 530/16- IEO 562
First Posted: February 21, 2018    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by European Institute of Oncology:
Robotic Mastectomy
Nipple Sparing Mastectomy
Conservative mastectomy
Breast reconstruction