Phase
Condition
N/ATreatment
N/AClinical Study ID
Ages 20-80 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
A. Indications and selection criteria for nipple sparing mastectomy (NSM) in generaland conventional nipple sparing mastectomy (C-NSM).
NSM will be offered to patients who are suitable for mastectomy but keen toconserve nipple areolar complex (NAC), with or without reconstruction. Patientsmust not have clinical or radiological involvement of the NAC. Patients withnipple involvement proven via intra-operative frozen section analysis willreceive 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 mastectomyapply 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 - III A), a tumor size less than 5 cm, no evidence ofmultiple lymph node metastasis, and no evidence of nipple, skin or chest wallinvasion.
Exclusion
Exclusion Criteria:
Contraindications for R-NSM, C-NSM or E-NSM include those with apparent NACinvolvement, inflammatory breast cancer, breast cancer with chest wall or skininvasion, locally advanced breast cancer, breast cancer with extensive axillary lymphnode metastasis (stage III B or later), and patients with severe co-morbid conditions,such as heart disease, renal failure, liver dysfunction, and poor performance statusas assessed by the primary physicians.
Relative contraindications include women with large (breast cup size larger thanE or breast mastectomy weight >600gm) or ptotic breast as the aesthetic outcomesmay be sub-optimal.
Study Design
Study Description
Connect with a study center
European Institute of Oncology
Milan,
ItalySite Not Available
Severance Hospital
Seoul,
Korea, Republic ofSite Not Available
Changhua Christian Hospital
Changhua,
TaiwanActive - Recruiting
Kaohsiung Medical University Hospital
Kaohsiung,
TaiwanActive - Recruiting
China Medical University Hospital
Taichung,
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan,
TaiwanSite Not Available
National Taiwan University Hospital
Taipei,
TaiwanSite Not Available
Shin Kong Wu Ho-Su Memorial Hospital
Taipei,
TaiwanActive - Recruiting
Taipei Municipal Wan Fang Hospital
Taipei,
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei,
TaiwanSite Not Available
Tri-Service General Hospital
Taipei,
TaiwanActive - Recruiting
Shuang-Ho Hospital - Taipei Medical University
Taipei county,
TaiwanActive - Recruiting
Chang Gung Memorial Hospital
Taoyuan,
TaiwanSite Not Available


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