Status:
UNKNOWN
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer-Prospective Study
Lead Sponsor:
Changhua Christian Hospital
Collaborating Sponsors:
Intuitive Surgical
Ministry of Science and Technology, Taiwan
Conditions:
Breast Cancer Female
Eligibility:
FEMALE
20-70 years
Phase:
NA
Brief Summary
This study will prospectively evaluate the surgical outcomes of robotic nipple sparing mastectomy (NSM) compared with endoscopic assisted NSM or conventional NSM in the management of breast cancer. On...
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 - 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
- \- 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.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2022
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT04037852
Start Date
October 1 2019
End Date
February 28 2022
Last Update
September 13 2021
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Changhua Christian Hospital
Changhua, Taiwan, 500
2
Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
Kaohsiung City, Taiwan
3
China Medical University Hospital, Taichung, Taiwan
Taichung, Taiwan
4
National Cheng Kung University Hospital
Tainan, Taiwan