Breast Cancer FemaleRCENSM-PNCT04037852
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer-Prospective Study
A study testing robotic assisted nipple sparing mastectomy, Endoscopic assisted nipple sparing mastectomy and Conventional nipple sparing mastectomy in people with Breast Cancer Female, run by Changhua Christian Hospital at 11 sites in Taiwan.
Trial 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. One-third patients would received R-NSM, another one-third received C-NSM while the other one-third would receive E-NSM. Read more about this study
- Who is it for?
- Ages 20 to 70 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- robotic assisted nipple sparing mastectomy, Endoscopic assisted nipple sparing mastectomy and Conventional nipple sparing mastectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 11 sitesTaiwan
- Study dates
- 1 Oct 2019to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- - 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.
Trial locations and contacts
11 sites in 1 country.
Shu-Hsin Pai, MS contact
11 sites in 1 country
Taiwan11 sites, 11 recruiting
- Recruiting
Changhua Christian Hospital
Changhua, 500
Hung-Wen Lai, MD, PhD, +886933496822, hwlai650420@yahoo.com.tw
Hung-Wen Lai, MD, PhD
- Recruiting
Kaohsiung Medical University Hospital, Kaohsiung, Taiwan
Kaohsiung City
Fu Ou-Yang, MD, PhD, kmufrank@gmail.com
Fang-Ming Chen, MD, PhD, fchen@kmu.edu.tw
- Recruiting
China Medical University Hospital, Taichung, Taiwan
Taichung
Liang-Chih Liu, MD, PhD, +886929034008, dr0363@yahoo.com.tw
Liang-Chih Liu, MD, PhD
- Recruiting
National Cheng Kung University Hospital
Tainan
Yao-Lung Kuo, MD, PhD, +88662353535 ext. 5224, ylkuo@mail.ncku.edu.tw
Yao-Lung Kuo, MD, PhD
- Recruiting
National Taiwan University Hospital
Taipei
Chiun-Sheng Huang, MD, PhD, huangcs@ntu.edu.tw
Chiun-Sheng Huang, MD, PhD
- Recruiting
Shin Kong Wu Ho-Su Memorial Hospital
Taipei
Tsui-Fen Cheng, MD, MPH, +886228332211 ext. 2086, Sgtw88@gmail.com
Tsui-Fen Cheng, MD, MPH
- Recruiting
Shuang-Ho Hospital - Taipei Medical University
Taipei
Chin-sheng Hung, MD, PhD, +886-2-27372181 ext. 8123, hungcs@tmu.edu.tw
Chin-sheng Hung, MD, PhD
- Recruiting
Taipei Municipal Wan Fang Hospital, Tawian
Taipei
Wei-Wen Chang, MD, weiwenabow@gmail.com
Wei-Wen Chang, MD
- Recruiting
Taipei Veterans General Hospital
Taipei
Ling-Ming Tseng, MD, lmtseng@vgptpe.gov.tw
Ling-Ming Tseng, MD
- Recruiting
Tri-Service General Hospital
Taipei
Guo-Shiou Liao, MD, guoshiou@ndmctsgh.edu.tw
Guo-Shiou Liao, MD
- Recruiting
Chang Gung Memorial Hospital, Taoyuan, Taiwan
Taoyuan
Wen-Ling Kuo, MD, PhD, +88633281200 ext. 3234, sylvie5285@gmail.com
Hsiu-Pei Tsai, MD, +88633281200 ext. 3219, tsaihp@cgmh.org.tw
About this study
Official title: Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer- A Prospective Registry Case Control Study
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. One-third patients would received R-NSM, another one-third received C-NSM while the other one-third would receive E-NSM.
Read 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, higher patient satisfaction, and maintained oncologic safety.
Minimal invasive surgery had become the main stream of operations, and new surgical innovations of NSM, like endoscopic nipple sparing mastectomy (E-NSM) or robotic nipple sparing mastectomy (R-NSM), were emerging and applied in the surgical treatment of breast cancer.
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%).
However, the 2-dimensional endoscopic in-line camera produces an inconsistent optical window around the curvature of the breast skin flap, and the internal mobility was limited and the dissection angles were inadequate with traditional endoscopic rigid tips instruments through single access. Due to the limitations of endoscopy instruments and technique difficulty, neither conventional E-NSM nor single access E-NSM was widespread used in breast cancer
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.
The preliminary results of R-NSM from current reported series and ours were safe, and associated with good cosmetic outcome and high patients' satisfaction. However, evidence comparing R-NSM to conventional NSM (C-NSM) or E-NSM was lacking.
In this study, the authors aim to investigate and analyze the clinical and aesthetic outcomes as well as the cost effectiveness of R-NSM through a prospective cohort of patients undergoing R-NSM, E-NSM or C-NSM.
- Conditions
- Breast Cancer Female
- Being tested
- robotic assisted nipple sparing mastectomy, Endoscopic assisted nipple sparing mastectomy, Conventional nipple sparing mastectomy
- Keywords
- 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robotic assisted nipple sparing mastectomyDevice
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.
Endoscopic assisted nipple sparing mastectomyProcedure or surgery
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%).
Conventional nipple sparing mastectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Robotic assisted nipple sparing mastectomy (R-NSM) | Experimental | R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM. Receives: Device: robotic assisted nipple sparing mastectomy |
| Conventional nipple sparing mastectomy (C-NSM) | Active comparator | Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy. Receives: Procedure: Conventional nipple sparing mastectomy |
| Endoscopic assisted nipple sparing mastectomy (E-NSM) | Active comparator | E-NSM, which is performed through small axillary and/or peri-areolar incisions, with endoscopic instruments to performed nipple sparing mastectomy. Receives: Procedure: Endoscopic assisted nipple sparing mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operation time
Overall operation time (minute), including breast cancer operations, lymph node surgery, and breast reconstructions
Measured: immediate post operation
Morbidity and complications
Delayed wound healing, degree of nipple ischemia/necrosis, seroma formation needing repeated aspiration, Blister formation, Skin flap ischemia necrosis, Hematoma formation, Implant loss will be collected and analyzed between different R-NSM, C-NSM and E-NSM groups.
Measured: within one month (30 days) post operation
Nipple areolar complex ischemia/necrosis grading
To evaluate the post-operative perfusion and survival of nipple areolar complex (NAC), a grading system was used in current study.
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:
- No ischemia/necrosis was observed in NAC (Grade I).
- Transient ischemia recovered without necrosis (Grade II).
- Partial ischemia/necrosis, recovered without loss of nipple volume (Grade III).
- Partial NAC necrosis with partial volume loss of nipple (Grade IV).
- Total NAC necrosis with all volume loss of nipple (Grade V). NAC ischemia/necrosis was segregated into no NAC necrosis (Grade I-III) and NAC necrosis (Grade IV-V).
The ischemia/necrosis of NAC between different R-NSM, C-NSM and E-NSM groups were recorded and compared.
Measured: evaluated in post operative 2 weeks to 3 months post operation
Surgical margin involvement
Surgical margin involvement was defined as tumor on the ink. The postoperative adjuvant hormone therapy, chemotherapy and radiotherapy were given to patients according to current breast cancer guidelines.
Measured: post operative 2 weeks after pathologic report available
Aesthetic outcome evaluation-Patient reported cosmetic outcome results
- Post-operative aesthetic results will be evaluated by comparing pre-operative and post-operative results. A self-reported 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".
Measured: 1-3 months after the operation when the wound was healed
Blood loss during operations
Blood loss (ml) from skin incision to completion of operations
Measured: immediate post operation
Hospital stay
Hospital stay (days) during operation period, recorded from admission to day of discharge at the breast cancer operation.
Measured: within 2 weeks of operation
Resection mastectomy weight
Mean mastectomy weight (gm) of patients received different mastectomy operations
Measured: immediate post operation
Reconstruction implant volume
Reconstruction implant volume (ml)
Measured: immediate post operation
Pain assessments
Pain assessments will also be collected as part of the post-operative parameters. Visual analogue scale (VAS) for pain assessments will be used in this study (range from 0 to 10 points, 0 indicate no pain, 10 indicate maximal pain ever experienced). VAS for pain per day would be recorded very day and compared.
Measured: within post operation two weeks
Secondary outcomes (3)
Cost- analysis of C-NSM versus R-NSM or E-NSM
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.
- The medical cost not reimbursed by national insurance, and needed to be paid for by patients include fees for breast reconstruction, robotic breast surgery, endoscopic breast surgery, instruments and prosthetic implants.
- Cost is expressed in New Taiwan dollars (NTDs) and in United States dollars (USDs). An exchange rate of 31 NTD/USD was used to convert NTD to USD.
Measured: post operation one month
Disease free survival
any local regional recurrence, or distant metastasis was recorded as an event. Disease free survival would be compared between R-NSM, C-NSM and E-NSM groups
Measured: 5 years post operation
Overall Survival
overall survival would be compared between R-NSM, C-NSM and E-NSM groups
Measured: 5 years post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- prospective registry of R-NSM versus C-NSM or E-NSM in the management of breast cancer. 3 arms study for comparisons
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Intuitive Surgical, Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Hung-Wen Lai, MD, PhD, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04037852
- Sponsor's protocol ID
- CCH-IRB-190414-P
- Other IDs
- 108-2314-B-371-006-
- Acronym
- RCENSM-P
- Status last verified
- Sep 2021
- First submitted
- 22 Jul 2019
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 16226028Leff 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.
PubMed 21128113Tukenmez 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.
PubMed 24401140Toesca 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.
PubMed 28692558Moran 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.
PubMed 24515565Park 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.
PubMed 24374705Lai 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.
PubMed 26950469Lai 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.
PubMed 29484564Sakamoto 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.
PubMed 19662457Toesca 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.
PubMed 27810700Sarfati 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.
PubMed 29959612Lai 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.
PubMed 30109537Lai 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.
PubMed 30360987Lai 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.
PubMed 30120037Lai HW, Chen DR, Liu LC, Chen ST, Kuo YL, Lin SL, Wu YC, Huang TC, Hung CS, Lin YJ, Tseng HS, Mok CW, Cheng FT. Robotic Versus Conventional or Endoscopic-assisted Nipple-sparing Mastectomy and Immediate Prosthesis Breast Reconstruction in the Management of Breast Cancer: A Prospectively Designed Multicenter Trial Comparing Clinical Outcomes, Medical Cost, and Patient-reported Outcomes (RCENSM-P). Ann Surg. 2024 Jan 1;279(1):138-146. doi: 10.1097/SLA.0000000000005924. Epub 2023 May 25.
PubMed 37226826
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer- A Prospective Registry Case Control Study
- ClinicalTrials.gov ID
- NCT04037852
- Acronym / sponsor ID
- RCENSM-P / CCH-IRB-190414-P
- Conditions
- Breast Cancer Female
- Keywords
- 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)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Collaborators
- Intuitive Surgical, Ministry of Science and Technology, Taiwan
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 30 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. One-third patients would received R-NSM, another one-third received C-NSM while the other one-third would receive E-NSM.
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, higher patient satisfaction, and maintained oncologic safety.
Minimal invasive surgery had become the main stream of operations, and new surgical innovations of NSM, like endoscopic nipple sparing mastectomy (E-NSM) or robotic nipple sparing mastectomy (R-NSM), were emerging and applied in the surgical treatment of breast cancer.
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%).
However, the 2-dimensional endoscopic in-line camera produces an inconsistent optical window around the curvature of the breast skin flap, and the internal mobility was limited and the dissection angles were inadequate with traditional endoscopic rigid tips instruments through single access. Due to the limitations of endoscopy instruments and technique difficulty, neither conventional E-NSM nor single access E-NSM was widespread used in breast cancer
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.
The preliminary results of R-NSM from current reported series and ours were safe, and associated with good cosmetic outcome and high patients' satisfaction. However, evidence comparing R-NSM to conventional NSM (C-NSM) or E-NSM was lacking.
In this study, the authors aim to investigate and analyze the clinical and aesthetic outcomes as well as the cost effectiveness of R-NSM through a prospective cohort of patients undergoing R-NSM, E-NSM or C-NSM.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- prospective registry of R-NSM versus C-NSM or E-NSM in the management of breast cancer. 3 arms study for comparisons
| Arm | Type | Receives |
|---|---|---|
| Robotic assisted nipple sparing mastectomy (R-NSM) | Experimental | Device: robotic assisted nipple sparing mastectomyR-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM. |
| Conventional nipple sparing mastectomy (C-NSM) | Active comparator | Procedure: Conventional nipple sparing mastectomyNipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy. |
| Endoscopic assisted nipple sparing mastectomy (E-NSM) | Active comparator | Procedure: Endoscopic assisted nipple sparing mastectomyE-NSM, which is performed through small axillary and/or peri-areolar incisions, with endoscopic instruments to performed nipple sparing mastectomy. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (2 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robotic assisted nipple sparing mastectomyR-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. | Device | Robotic assisted nipple sparing mastectomy (R-NSM) |
| Endoscopic assisted nipple sparing mastectomyE-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%). | Procedure or surgery | Endoscopic assisted nipple sparing mastectomy (E-NSM) |
| Conventional nipple sparing mastectomyNipple-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. | Procedure or surgery | Conventional nipple sparing mastectomy (C-NSM) |
Primary outcome
Operation time
Time frame: immediate post operation
Overall operation time (minute), including breast cancer operations, lymph node surgery, and breast reconstructions
Morbidity and complications
Time frame: within one month (30 days) post operation
Delayed wound healing, degree of nipple ischemia/necrosis, seroma formation needing repeated aspiration, Blister formation, Skin flap ischemia necrosis, Hematoma formation, Implant loss will be collected and analyzed between different R-NSM, C-NSM and E-NSM groups.
Nipple areolar complex ischemia/necrosis grading
Time frame: evaluated in post operative 2 weeks to 3 months post operation
To evaluate the post-operative perfusion and survival of nipple areolar complex (NAC), a grading system was used in current study. 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: 1. No ischemia/necrosis was observed in NAC (Grade I). 2. Transient ischemia recovered without necrosis (Grade II). 3. Partial ischemia/necrosis, recovered without loss of nipple volume (Grade III). 4. Partial NAC necrosis with partial volume loss of nipple (Grade IV). 5. Total NAC necrosis with all volume loss of nipple (Grade V). NAC ischemia/necrosis was segregated into no NAC necrosis (Grade I-III) and NAC necrosis (Grade IV-V). The ischemia/necrosis of NAC between different R-NSM, C-NSM and E-NSM groups were recorded and compared.
Surgical margin involvement
Time frame: post operative 2 weeks after pathologic report available
Surgical margin involvement was defined as tumor on the ink. The postoperative adjuvant hormone therapy, chemotherapy and radiotherapy were given to patients according to current breast cancer guidelines.
Aesthetic outcome evaluation-Patient reported cosmetic outcome results
Time frame: 1-3 months after the operation when the wound was healed
- Post-operative aesthetic results will be evaluated by comparing pre-operative and post-operative results. A self-reported 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".
Blood loss during operations
Time frame: immediate post operation
Blood loss (ml) from skin incision to completion of operations
Hospital stay
Time frame: within 2 weeks of operation
Hospital stay (days) during operation period, recorded from admission to day of discharge at the breast cancer operation.
Resection mastectomy weight
Time frame: immediate post operation
Mean mastectomy weight (gm) of patients received different mastectomy operations
Reconstruction implant volume
Time frame: immediate post operation
Reconstruction implant volume (ml)
Pain assessments
Time frame: within post operation two weeks
Pain assessments will also be collected as part of the post-operative parameters. Visual analogue scale (VAS) for pain assessments will be used in this study (range from 0 to 10 points, 0 indicate no pain, 10 indicate maximal pain ever experienced). VAS for pain per day would be recorded very day and compared.
3 secondary outcomes
Cost- analysis of C-NSM versus R-NSM or E-NSM
Time frame: post operation one month
Disease free survival
Time frame: 5 years post operation
Overall Survival
Time frame: 5 years post operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Background: PubMed 16226028Petit 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.
- Background: PubMed 21128113Leff 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.
- Background: PubMed 24401140Tukenmez 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.
- Background: PubMed 28692558Toesca 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.
- Background: PubMed 24515565Moran 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.
- Background: PubMed 24374705Park 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.
- Results publication: PubMed 26950469Lai 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.
- Results publication: PubMed 29484564Lai 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.
- Results publication: PubMed 19662457Sakamoto 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.
- Results publication: PubMed 27810700Toesca 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.
- Results publication: PubMed 29959612Sarfati 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.
- Results publication: PubMed 30109537Lai 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Hsin Pai, MS contact
Hung-Wen Lai, MD, PhD principal investigator
Changhua Christian Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing robotic assisted nipple sparing mastectomy, Endoscopic assisted nipple sparing mastectomy and Conventional nipple sparing mastectomy in people with Breast Cancer Female, run by Changhua Christian Hospital at 11 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hung-Wen Lai, MD, PhD (+886933496822, hwlai650420@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: immediate post operation). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04037852, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.