Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast Cancer

NCT04049305 | Unknown DMC FDA Device

• 2 other identifiers: CCH-IRB-190414-RMOST 108-2314-B-371-006-
• Study Type: interventional
• Target: 900
• Locations: 3 countries
• Sites: 13

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 management of breast cancer. Multi-centers pooled data analysis would be performed for comparisons of R-NSM compared with C-NSM or E-NSM.

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; immediate prothesis breast reconstruction

Outcome Measures

Primary Outcomes (15)

• Operation time

  Overall operation time (minute), from skin incision to completion of operations. Compared overall operation time between R-NSM, C-NSM and E-NSM.

  immediate post operation

• Wound healing status

  rate of Delayed wound healing between R-NSM, C-NSM and E-NSM groups.

  within one month (30 days) post operation

• Skin blister formation

  rate of skin blister formation between R-NSM, C-NSM and E-NSM groups.

  within one month (30 days) post operation

• Skin flap ischemia/necrosis rate

  rate of skin flap ischemia/necrosis between R-NSM, C-NSM and E-NSM groups.

  within one month (30 days) post operation

• Implant loss rate

  rate of implant loss between R-NSM, C-NSM and E-NSM groups.

  within one month (30 days) post operation

• Post operation Bleeding/hematoma rate

  rate of post operative bleeding/hematoma rate between R-NSM, C-NSM and E-NSM groups.

  within one month (30 days) post operation

• Post operation Bleeding/hematoma rate

  rate of post operative bleeding/hematoma between R-NSM, C-NSM and E-NSM groups.

  within one month (30 days) post operation

• Seroma formation rate

  rate of post operative seroma formation needing repeat aspiration between R-NSM, C-NSM and E-NSM groups.

  within one month (30 days) post operation

• Grade of Nipple areolar complex ischemia/necrosis

  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.

  evaluated in post operative 2 weeks to 3 months post operation

• Rate of Surgical margin involvement in specimen pathologic examination

  Rate of Surgical margin involvement in specimen during pathologic examination, and surgical margin involvement was defined as tumor on the ink.

  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 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".

  1-3 months after the operation when the wound was healed

• Blood loss during operation

  Blood loss (ml) during operation was compared between groups (R-NSM, C-NSM and R-NSM)

  immediate post operation

• Hospital stay

  Hospital stay (days) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)

  within 2 weeks of operation

• Mean mastectomy weight

  Mean mastectomy weight (gm) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)

  immediate post operation

• Reconstruction implant volume

  Reconstruction implant volume (ml) of patients receiving different operations (R-NSM, C-NSM, and E-NSM)

  immediate post operation

Secondary Outcomes (3)

• Cost- analysis of C-NSM versus R-NSM or E-NSM

  post operation one month

• Disease free Survival

  5 years post operation

• Overall survival

  5 years post operation

Study Arms (3)

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.

Device: Robotic assisted nipple sparing mastectomy (R-NSM)

Conventional nipple sparing mastectomy (C-NSM)

ACTIVE COMPARATOR

Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy.

Procedure: conventional nipple sparing mastectomy (C-NSM)

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.

Procedure: Endoscopic assisted nipple sparing mastectomy (E-NSM)

Interventions

Robotic assisted nipple sparing mastectomy (R-NSM) DEVICE

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.

Robotic assisted nipple sparing mastectomy (R-NSM)

conventional nipple sparing mastectomy (C-NSM) PROCEDURE

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.

Conventional nipple sparing mastectomy (C-NSM)

Endoscopic assisted nipple sparing mastectomy (E-NSM) PROCEDURE

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%).

Endoscopic assisted nipple sparing mastectomy (E-NSM)

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Changhua Christian Hospital: lead
• Ministry of Science and Technology, Taiwan: collaborator
• Intuitive Surgical: collaborator

Study Sites (13)

European Institute of Oncology

Milan, Italy

NOT YET RECRUITING

Severance Hospital

Seoul, South Korea

NOT YET RECRUITING

Changhua Christian Hospital

Changhua, Taiwan

RECRUITING

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

RECRUITING

China Medical University Hospital

Taichung, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

NOT YET RECRUITING

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

RECRUITING

Taipei Municipal Wan Fang Hospital

Taipei, Taiwan

NOT YET RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

NOT YET RECRUITING

Tri-Service General Hospital

Taipei, Taiwan

RECRUITING

Shuang-Ho Hospital - Taipei Medical University

Taipei County, Taiwan

RECRUITING

Chang Gung Memorial Hospital

Taoyuan District, Taiwan

NOT YET RECRUITING

Related Publications (14)

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• 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.

  PMID: 24401140 BACKGROUND

• 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.

  PMID: 28692558 BACKGROUND

• 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.

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• 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.

  PMID: 29484564 RESULT

• 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.

  PMID: 27810700 RESULT

• 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.

  PMID: 29959612 RESULT

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  PMID: 30109537 RESULT

• 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.

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  PMID: 30120037 RESULT

Study Officials

• Hung-Wen Lai, MD, PhD

  Changhua Christian Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hung-Wen Lai, MD, PhD

CONTACT

+886933496822; hwlai650420@yahoo.com.tw

Shu-Hsin Pai, MD, PhD

CONTACT

+88647238595; 69584@cch.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: None (Open Label) Retrospective, non-randomized, non-masking, open label, 3 arms
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Retrospective, multi-centers pooled data analysis of R-NSM versus C-NSM or E-NSM in the management of breast cancer. 3 arms study for comparisons

Study Record Dates

• First Submitted: July 24, 2019
• First Posted: August 8, 2019
• Study Start: August 22, 2019
• Primary Completion: July 31, 2021
• Study Completion: December 31, 2021
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1); IT (1); TW (11)