Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)

Prospective Pilot Study of Robot-Assisted Nipple Sparing Mastectomy (RNSM)

This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.

With the advances of breast reconstruction after mastectomy for the treatment of breast diseases including breast cancer, surgical techniques have evolved to preserve the skin flaps and nipple areolar complex (NAC) to give better aesthetic outcome without compromising outcome. Mastectomy that preserves the NAC is called nipple sparing mastectomy (NSM). NSM can provide major psychosocial benefits for patients but is technically demanding and challenging to perform. Total mammary glandular excision in NSM can be technically challenging due to small size of the incision and poor visualization of dissection plane. Recent studies demonstrate feasibility and safety of performing minimally invasive robot-assisted NSM (RNSM). The technique of RNSM is still novel.

This is a single-arm pilot study for feasibility and safety of RNSM.

Inclusion Criteria:

• Surgical candidates, per standard of care for:

  • Nipple sparing resection and reconstruction OR
  • Prophylactic mastectomy for risk reduction mastectomy OR
  • Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer

• Surgical candidates for open NSM, per standard of care, with regards to patient anatomic factors and tumor location

• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

• Pregnant or nursing women

• Patients with:

  • Inflammatory breast cancer
  • Skin involvement with tumor
  • Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor
  • Grade 3 ptosis of nipple

• Smokers with heavy current use of nicotine (defined as > 20 cigarettes/day)

• Patients that are high risk for anesthesia, as documented in medical record

• Patients that do not have the ability to give informed consent

• Prisoner status at surgical clinic visit

• Bra cup size greater than C cup

• Previous thoracic radiation history (for any reason)