INSPIRE 1
Research type
Research Study
Full title
INTERNATIONAL NIPPLE SPARING MASTECTOMY REGISTER
IRAS ID
211131
Contact name
Riccardo Audiso
Contact email
Sponsor organisation
St Helens & Knowsley Teaching Hospitals
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
Nipple Sparing Mastectomy (NSM) entails the conservation of the nipple areola complex
(NAC) as well as the skin envelope while performing a complete excision of all the mammary gland; NSM is a recently introduced alternative to modified radical, total and skin sparing mastectomy where the NAC is removed and it is also different from subcutaneous mastectomy. NSM and immediate breast reconstruction has been practiced more and more often in the last decade in treating invasive breast cancer as well as precancerous conditions such as DCIS and for women with an increased risk of developing breast cancer. One significant advantage of the NSM technique is the removal of the whole breast tissue as a radical surgical procedure while preserving native breast integrity, the nipple-areola complex as well as the submammary fold, therefore improving the cosmetic outcomes.
Several recently reports seem to suggest that the oncologic outcomes of NSM are comparable
to a skin-sparing mastectomy, with locoregional recurrence rates as low as 2 % at 3-year follow-up. As NSM techniques have evolved over time, complications have been reduced to acceptably low rates, making the approach technically feasible and safe. Furthermore, excellent aesthetic outcomes and high levels of patient satisfaction after reconstruction have been achieved; this is particularly important for women considering bilateral mastectomy for the purpose of reducing the risk of developing a breast cancer.
As rates of NSM continue to increase, it is important to retrieve confirmatory evidence in
support of the oncologic safety of the technique for therapeutic as well as risk reducing
indications in high-risk patients. Women, whether affected by breast cancer or exposed to an increased risk, deserve full information on the advantages and drawbacks of NSM, as derived from solid investigations.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
16/EM/0295
Date of REC Opinion
12 Aug 2016
REC opinion
Further Information Favourable Opinion