Status:
UNKNOWN
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast Cancer
Lead Sponsor:
Changhua Christian Hospital
Collaborating Sponsors:
Ministry of Science and Technology, Taiwan
Intuitive Surgical
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
20-80 years
Phase:
NA
Brief Summary
This study will retrospectively collect and evaluate the surgical outcomes of robotic nipple sparing mastectomy (R-NSM) compared with endoscopic assisted NSM (E-NSM) or conventional NSM (C-NSM) in the...
Detailed Description
Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, ...
Eligibility Criteria
Inclusion
- 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 - III A), 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
- 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 sub-optimal.
Key Trial Info
Start Date :
August 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2021
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04049305
Start Date
August 22 2019
End Date
December 31 2021
Last Update
July 16 2020
Active Locations (13)
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1
European Institute of Oncology
Milan, Italy
2
Severance Hospital
Seoul, South Korea
3
Changhua Christian Hospital
Changhua, Taiwan
4
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan