Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer-Prospective Study (RCENSM-P)
Breast Cancer Female
About this trial
This is an interventional treatment trial for Breast Cancer Female focused on measuring nipple sparing mastectomy, robotic nipple sparing mastectomy (R-NSM), conventional nipple sparing mastectomy (C-NSM), endoscopic assisted nipple sparing mastectomy (E-NSM), immediate breast reconstruction (IBR), immediate prothesis breast reconstruction (IPBR)
Eligibility Criteria
Inclusion Criteria:
- A. Indications and selection criteria for nipple sparing mastectomy (NSM) in general and conventional nipple sparing mastectomy (C-NSM)
- NSM will be offered to patients who are suitable for mastectomy but keen to conserve nipple areolar complex (NAC), with or without reconstruction. Patients must not have clinical or radiological involvement of the NAC. Patients with nipple involvement proven via intra-operative frozen section analysis will receive NAC excision and hence a skin-sparing mastectomy (SSM) performed instead.
B. Indications and selection criteria for robotic nipple sparing mastectomy (R-NSM) or endoscopic nipple sparing mastectomy (E-NSM)
- The general inclusion criteria or pre-requisite for nipple sparing mastectomy apply to R-NSM or E-NSM as well.
- In addition, R-NSM or E-NSM should only include early stage breast cancer (carcinoma in situ, stage I - IIIA), a tumor size less than 5 cm, no evidence of multiple lymph node metastasis, and no evidence of nipple, skin or chest wall invasion.
Exclusion Criteria:
- - Contraindications for R-NSM, C-NSM or E-NSM include those with apparent NAC involvement, inflammatory breast cancer, breast cancer with chest wall or skin invasion, locally advanced breast cancer, breast cancer with extensive axillary lymph node metastasis (stage III B or later), and patients with severe co-morbid conditions, such as heart disease, renal failure, liver dysfunction, and poor performance status as assessed by the primary physicians
- Relative contraindications include women with large (breast cup size larger than E or breast mastectomy weight >600gm) or ptotic breast as the aesthetic outcomes may be suboptimal.
Sites / Locations
- Changhua Christian HospitalRecruiting
- Kaohsiung Medical University Hospital, Kaohsiung, TaiwanRecruiting
- China Medical University Hospital, Taichung, TaiwanRecruiting
- National Cheng Kung University HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Shin Kong Wu Ho-Su Memorial HospitalRecruiting
- Shuang-Ho Hospital - Taipei Medical UniversityRecruiting
- Taipei Municipal Wan Fang Hospital, TawianRecruiting
- Taipei Veterans General HospitalRecruiting
- Tri-Service General HospitalRecruiting
- Chang Gung Memorial Hospital, Taoyuan, TaiwanRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
Robotic assisted nipple sparing mastectomy (R-NSM)
Conventional nipple sparing mastectomy (C-NSM)
Endoscopic assisted nipple sparing mastectomy (E-NSM)
R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM.
Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy.
E-NSM, which is performed through small axillary and/or peri-areolar incisions, with endoscopic instruments to performed nipple sparing mastectomy.