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

The Ohio State University

Status: Active, not recruiting

Conditions: Prognostic Stage IA Breast Cancer AJCC v8; Prognostic Stage IB Breast Cancer AJCC v8; Prognostic Stage I Breast Cancer AJCC v8; Prognostic Stage IIB Breast Cancer AJCC v8; Prognostic Stage IIA Breast Cancer AJCC v8; Anatomic Stage IIA Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIB Breast Cancer AJCC v8; Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage IIIA Breast Cancer AJCC v8; Prognostic Stage II Breast Cancer AJCC v8; Anatomic Stage IB Breast Cancer AJCC v8; Anatomic Stage IA Breast Cancer AJCC v8; Prophylactic Mastectomy; Ductal Breast Carcinoma In Situ

Treatments: Other: Survey Administration; Device: RNSM; Procedure: Robot-assisted Nipple Sparing Mastectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04537312

NCI-2020-05349 (Registry Identifier)

OSU-19199

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

Supportive care (RNSM, surveys)

Experimental group

Description:

RNMS Surveys

Treatment:

Procedure: Robot-assisted Nipple Sparing Mastectomy

Device: RNSM

Other: Survey Administration