Nipple Delay Prior to Nipple Sparing Mastectomy: A Pilot RCT

The surgical management of breast cancer has evolved over the last few decades, with cancer extirpation becoming less aggressive in parallel with advances in breast reconstruction. Preservation of the nipple-areolar complex (NAC) at time of mastectomy (nipple-sparing mastectomy, NSM), represents a natural progression within reconstructive and surgical oncology to preserve maximum native skin as is oncologically feasible. NSM is associated with improved satisfaction, body image and psychological adjustment. NSM has received increased attention in the lay media, because the ability to preserve the entire breast envelope appeals to patients facing the decision to undergo mastectomy.

Clinician attention regarding NSM has focused on the oncologic implications of the residual breast tissue. Several systematic reviews of prospective and retrospective studies (level II to IV) have concluded that NSM does not impair overall or breast cancer specific survival outcomes compared to skin-sparing mastectomy. This has fostered the adoption of NSM within North America and Europe. The rate of occult NAC involvement ranges from 6 - 30%.

However, the intended purpose of NSM to preserve the NAC may be circumvented if a tenuous sub-dermal blood supply compromises NAC viability. Rates of NAC necrosis are variable, from 0% to nearly 50% of cases 5,6. Few studies explored strategies to prevent this potentially devastating complication. Recent case series employ the use of the surgical delay phenomenon to improve vascular supply and reduce NAC necrosis during NSM 9,10, however this strategy has not been directly compared with standard NSM.

There have been no controlled studies to investigate mechanisms to reduce the chance of potentially devestating complication of NAC necrosis or minimize the clinical impact of occult tumor involvement in the NAC. Because our study is a pilot feasibility study, we have 3 specific rationale to support our design using a pilot study first:

1. : Given lack of evidence to support impaired cancer outcomes, there has been greater interest in NSM within our breast cancer community. Prior to initiating a full trial, it is paramount to determine the extent to which the intervention can be provided as intended.
2. There are a number of well-described challenges to undertaking a RCT of a surgical intervention, and the extent to which women consent to participate, maintain randomized treatment allocation and adhere to study protocol will inform whether this study is feasible at a larger scale. It has not been determined whether candidates for NSM would accept an additional surgical procedure to reduce the risk of NAC necrosis. Lastly, there is the opportunity to identify and revise organization and protocols prior to execution within a full trial.
3. : Given there is wide variation in reported rates of NAC necrosis, it is important to determine the incidence of NAC necrosis within our institutions and use this information to generate and inform sample size calculation. The direction of benefit and preliminary estimates of the effect of the intervention will clarify the choice of primary and secondary outcomes and feasibility for a larger scale study.