- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04049305
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast Cancer (RCENSM-R)
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer- A Retrospective Study With Multi-center Pooled Data Analysis
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hung-Wen Lai, MD, PhD
- Phone Number: +886933496822
- Email: hwlai650420@yahoo.com.tw
Study Contact Backup
- Name: Shu-Hsin Pai, MD, PhD
- Phone Number: 8383 +88647238595
- Email: 69584@cch.org.tw
Study Locations
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Milan, Italy
- Not yet recruiting
- European Institute of Oncology
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Contact:
- Antonio Toesca, MD
- Email: antonio.toesca@ieo.it
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Principal Investigator:
- Antonio Toesca, MD
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Seoul, Korea, Republic of
- Not yet recruiting
- Severance Hospital
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Contact:
- Hyung-Seok Park, MD, PhD
- Email: imgenius@yuhs.ac
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Principal Investigator:
- Hyung-Seok Park, MD, PhD
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Changhua, Taiwan
- Recruiting
- Changhua Christian Hospital
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Contact:
- Hung-Wen Lai, MD, PhD
- Phone Number: +886933496822
- Email: hwlai650420@yahoo.com.tw
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Principal Investigator:
- Hung-Wen Lai, MD, PhD
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Sub-Investigator:
- Shou-Tung Chen, MD
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Sub-Investigator:
- Dar-Ren Chen, MD
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Kaohsiung, Taiwan
- Recruiting
- Kaohsiung Medical University Hospital
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Contact:
- Fu Ou-Yang, MD, PhD
- Email: kmufrank@gmail.com
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Contact:
- Fang-Ming Chen, MD, PhD
- Email: fchen@kmu.edu.tw
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Principal Investigator:
- Fu Ou-Yang, MD, PhD
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Principal Investigator:
- Fang-Ming Chen, MD, PhD
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Taichung, Taiwan
- Recruiting
- China Medical University Hospital
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Principal Investigator:
- Liang-Chih Liu, MD, PhD
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Contact:
- Liang-Chih Liu, MD, PhD
- Email: dr0363@yahoo.com.tw
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Tainan, Taiwan
- Not yet recruiting
- National Cheng Kung University Hospital
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Principal Investigator:
- Yao-Lung Kuo, MD, PhD
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Contact:
- Yao-Lung Kuo, MD, PhD
- Email: ylkuo@mail.ncku.edu.tw
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Taipei, Taiwan
- Recruiting
- Tri-Service General Hospital
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Contact:
- Guo-Shiou Liao, MD
- Email: guoshiou@ndmctsgh.edu.tw
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Principal Investigator:
- Guo-Shiou Liao, MD
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Taipei, Taiwan
- Recruiting
- Shin Kong Wu Ho-Su Memorial Hospital
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Contact:
- Tsui-Fen Cheng, MD
- Email: Sgtw88@gmail.com
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Principal Investigator:
- Tsui-Fen Cheng, MD
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Taipei, Taiwan
- Not yet recruiting
- National Taiwan University Hospital
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Contact:
- Chiun-Sheng Huang, MD, PhD
- Email: huangcs@ntu.edu.tw
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Principal Investigator:
- Chiun-Sheng Huang, MD, PhD
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Taipei, Taiwan
- Not yet recruiting
- Taipei Municipal Wan Fang Hospital
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Contact:
- Wei-Wen Chang, MD
- Email: weiwenabow@gmail.com
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Principal Investigator:
- Wei-Wen Chang, MD
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Taipei, Taiwan
- Not yet recruiting
- Taipei Veterans General Hospital
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Contact:
- Ling-Ming Tseng, MD
- Email: lmtseng@vgptpe.gov.tw
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Taipei county, Taiwan
- Recruiting
- Shuang-Ho Hospital - Taipei Medical University
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Contact:
- Chin-sheng Hung, MD, PhD
- Phone Number: 8123 +886-2-27372181
- Email: hungcs@tmu.edu.tw
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Principal Investigator:
- Chin-sheng Hung, MD, PhD
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Taoyuan, Taiwan
- Not yet recruiting
- Chang Gung Memorial Hospital
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Principal Investigator:
- Wen-Ling Kuo, MD, PhD
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Sub-Investigator:
- Hsiu-Pei Tsai, MD
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Contact:
- Wen-Ling Kuo, MD, PhD
- Email: sylvie5285@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 - 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 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 sub-optimal.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Robotic assisted nipple sparing mastectomy (R-NSM)
R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM.
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R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy.
R-NSM, which incorporated 3-dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM.
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Active Comparator: Conventional nipple sparing mastectomy (C-NSM)
Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy.
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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, higher patient satisfaction, and maintained oncologic safety.
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Active Comparator: Endoscopic assisted nipple sparing mastectomy (E-NSM)
E-NSM, which is performed through small axillary and/or peri-areolar incisions, with endoscopic instruments to performed nipple sparing mastectomy.
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E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome.
Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions.
E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%),
was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%).
New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Operation time
Time Frame: immediate post operation
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Overall operation time (minute), from skin incision to completion of operations.
Compared overall operation time between R-NSM, C-NSM and E-NSM.
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immediate post operation
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Wound healing status
Time Frame: within one month (30 days) post operation
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rate of Delayed wound healing between R-NSM, C-NSM and E-NSM groups.
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within one month (30 days) post operation
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Skin blister formation
Time Frame: within one month (30 days) post operation
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rate of skin blister formation between R-NSM, C-NSM and E-NSM groups.
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within one month (30 days) post operation
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Skin flap ischemia/necrosis rate
Time Frame: within one month (30 days) post operation
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rate of skin flap ischemia/necrosis between R-NSM, C-NSM and E-NSM groups.
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within one month (30 days) post operation
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Implant loss rate
Time Frame: within one month (30 days) post operation
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rate of implant loss between R-NSM, C-NSM and E-NSM groups.
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within one month (30 days) post operation
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Post operation Bleeding/hematoma rate
Time Frame: within one month (30 days) post operation
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rate of post operative bleeding/hematoma rate between R-NSM, C-NSM and E-NSM groups.
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within one month (30 days) post operation
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Post operation Bleeding/hematoma rate
Time Frame: within one month (30 days) post operation
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rate of post operative bleeding/hematoma between R-NSM, C-NSM and E-NSM groups.
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within one month (30 days) post operation
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Seroma formation rate
Time Frame: within one month (30 days) post operation
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rate of post operative seroma formation needing repeat aspiration between R-NSM, C-NSM and E-NSM groups.
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within one month (30 days) post operation
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Grade of Nipple areolar complex ischemia/necrosis
Time Frame: evaluated in post operative 2 weeks to 3 months post operation
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The perfusion of NAC was evaluated in 2 weeks to 3 months post operation. The survival of NAC was confirmed at post-operative 3 months. The NAC ischemia/necrosis was divided into 5 different grades, which were:
The ischemia/necrosis of NAC between different R-NSM, C-NSM and E-NSM groups were recorded and compared. |
evaluated in post operative 2 weeks to 3 months post operation
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Rate of Surgical margin involvement in specimen pathologic examination
Time Frame: post operative 2 weeks after pathologic report available
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Rate of Surgical margin involvement in specimen during pathologic examination, and surgical margin involvement was defined as tumor on the ink.
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post operative 2 weeks after pathologic report available
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Aesthetic outcome evaluation-Patient reported cosmetic outcome results
Time Frame: 1-3 months after the operation when the wound was healed
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- Post-operative aesthetic results will be evaluated by comparing pre-operative and post-operative results.
A selfreported questionnaire to evaluate the cosmetic outcome of breast cancer patients with mastectomy following breast reconstruction was conducted 1-3 months after the operation.
This questionnaire comprises of 10 questions based on 4 itemized scales, which will be graded as "1, dis-satisfied", "2, fair", "3, satisfied", and "4, very satisfied".
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1-3 months after the operation when the wound was healed
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Blood loss during operation
Time Frame: immediate post operation
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Blood loss (ml) during operation was compared between groups (R-NSM, C-NSM and R-NSM)
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immediate post operation
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Hospital stay
Time Frame: within 2 weeks of operation
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Hospital stay (days) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)
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within 2 weeks of operation
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Mean mastectomy weight
Time Frame: immediate post operation
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Mean mastectomy weight (gm) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)
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immediate post operation
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Reconstruction implant volume
Time Frame: immediate post operation
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Reconstruction implant volume (ml) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)
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immediate post operation
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost- analysis of C-NSM versus R-NSM or E-NSM
Time Frame: post operation one month
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The medical cost associated with robotic versus conventional or endoscopic assisted NSM will be collected and compared. The medical cost incurred for each procedure include overall hospital cost. Information on surgery related expenses will obtained from the finance department of the institution. In Taiwan, the operation fees of breast reconstruction and robotic breast surgery are not reimbursed by national insurance. The medical cost covered by national insurance include operations fee for breast cancer and/or axillary lymph node surgery, anesthesia, admission fee, and all other medical related expenses.
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post operation one month
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Disease free Survival
Time Frame: 5 years post operation
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disease-free survival between R-NSM, C-NSM or E-NSM .
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5 years post operation
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Overall survival
Time Frame: 5 years post operation
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overall survival between R-NSM, C-NSM or E-NSM .
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5 years post operation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hung-Wen Lai, MD, PhD, Changhua Christian Hospital
Publications and helpful links
General Publications
- Toesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique. Ann Surg. 2017 Aug;266(2):e28-e30. doi: 10.1097/SLA.0000000000001397. No abstract available.
- Petit JY, Veronesi U, Luini A, Orecchia R, Rey PC, Martella S, Didier F, De Lorenzi F, Rietjens M, Garusi C, Sonzogni A, Galimberti V, Leida E, Lazzari R, Giraldo A. When mastectomy becomes inevitable: the nipple-sparing approach. Breast. 2005 Dec;14(6):527-31. doi: 10.1016/j.breast.2005.08.028. Epub 2005 Oct 12.
- Tukenmez M, Ozden BC, Agcaoglu O, Kecer M, Ozmen V, Muslumanoglu M, Igci A. Videoendoscopic single-port nipple-sparing mastectomy and immediate reconstruction. J Laparoendosc Adv Surg Tech A. 2014 Feb;24(2):77-82. doi: 10.1089/lap.2013.0172. Epub 2014 Jan 8.
- Moran MS, Schnitt SJ, Giuliano AE, Harris JR, Khan SA, Horton J, Klimberg S, Chavez-MacGregor M, Freedman G, Houssami N, Johnson PL, Morrow M. Society of Surgical Oncology-American Society for Radiation Oncology consensus guideline on margins for breast-conserving surgery with whole-breast irradiation in stages I and II invasive breast cancer. Ann Surg Oncol. 2014 Mar;21(3):704-16. doi: 10.1245/s10434-014-3481-4. Epub 2014 Feb 10.
- Park SW, Lee TJ, Kim EK, Eom JS. Managing necrosis of the nipple-areola complex in breast reconstruction after nipple-sparing mastectomy: immediate nipple-areola complex reconstruction with banked skin. Plast Reconstr Surg. 2014 Jan;133(1):73e-74e. doi: 10.1097/01.prs.0000436805.58165.d3. No abstract available.
- Lai HW, Chen ST, Chen DR, Chen SL, Chang TW, Kuo SJ, Kuo YL, Hung CS. Current Trends in and Indications for Endoscopy-Assisted Breast Surgery for Breast Cancer: Results from a Six-Year Study Conducted by the Taiwan Endoscopic Breast Surgery Cooperative Group. PLoS One. 2016 Mar 7;11(3):e0150310. doi: 10.1371/journal.pone.0150310. eCollection 2016.
- Lai HW, Lin SL, Chen ST, Kuok KM, Chen SL, Lin YL, Chen DR, Kuo SJ. Single-Axillary-Incision Endoscopic-Assisted Hybrid Technique for Nipple-Sparing Mastectomy: Technique, Preliminary Results, and Patient-Reported Cosmetic Outcome from Preliminary 50 Procedures. Ann Surg Oncol. 2018 May;25(5):1340-1349. doi: 10.1245/s10434-018-6383-z. Epub 2018 Feb 26.
- Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.
- Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.
- Lai HW, Chen ST, Lin SL, Chen CJ, Lin YL, Pai SH, Chen DR, Kuo SJ. Robotic Nipple-Sparing Mastectomy and Immediate Breast Reconstruction with Gel Implant: Technique, Preliminary Results and Patient-Reported Cosmetic Outcome. Ann Surg Oncol. 2019 Jan;26(1):42-52. doi: 10.1245/s10434-018-6704-2. Epub 2018 Aug 14.
- Lai HW, Wang CC, Lai YC, Chen CJ, Lin SL, Chen ST, Lin YJ, Chen DR, Kuo SJ. The learning curve of robotic nipple sparing mastectomy for breast cancer: An analysis of consecutive 39 procedures with cumulative sum plot. Eur J Surg Oncol. 2019 Feb;45(2):125-133. doi: 10.1016/j.ejso.2018.09.021. Epub 2018 Oct 17.
- Lai HW, Huang RH, Wu YT, Chen CJ, Chen ST, Lin YJ, Chen DR, Lee CW, Wu HK, Lin HY, Kuo SJ. Clinicopathologic factors related to surgical margin involvement, reoperation, and residual cancer in primary operable breast cancer - An analysis of 2050 patients. Eur J Surg Oncol. 2018 Nov;44(11):1725-1735. doi: 10.1016/j.ejso.2018.07.056. Epub 2018 Aug 1.
- Sakamoto N, Fukuma E, Higa K, Ozaki S, Sakamoto M, Abe S, Kurihara T, Tozaki M. Early results of an endoscopic nipple-sparing mastectomy for breast cancer. Ann Surg Oncol. 2009 Dec;16(12):3406-13. doi: 10.1245/s10434-009-0661-8.
- Leff DR, Vashisht R, Yongue G, Keshtgar M, Yang GZ, Darzi A. Endoscopic breast surgery: where are we now and what might the future hold for video-assisted breast surgery? Breast Cancer Res Treat. 2011 Feb;125(3):607-25. doi: 10.1007/s10549-010-1258-4. Epub 2010 Dec 3.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCH-IRB-190414-R
- MOST 108-2314-B-371-006- (Other Grant/Funding Number: Ministry of Science and Technology, Taiwan)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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