Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction

NCT04108117 | Completed

• 1 other identifier: 4-2019-0834
• Study Type: observational
• Target: 659
• Locations: 1 country
• Sites: 1

Brief Summary

Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction. However, most studies were conducted by single centers and had small samples. Furthermore, there is a lack of studies comparing surgical and oncologic outcomes between robotic nipple-sparing mastectomy and conventional nipple-sparing mastectomy. For this reason, this study evaluates surgical and oncologic outcomes of robotic nipple-sparing mastectomy with immediate reconstruction using international multi-center data.

Conditions

Postoperative Complications; Recurrence; Breast Neoplasms; Breast Cancer; BRCA1 Mutation; BRCA2 Mutation; Surgery; Surgery--Complications

Keywords

Robotic mastectomy; Breast neoplasms; Postoperative complications; Recurrence; Prognosis; Survivals; Nipple sparing mastectomy; Immediate reconstruction

Outcome Measures

Primary Outcomes (4)

• Postoperative complication rates in 30 days

  Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.

  Postoperative 30 days

• Clavien-Dindo grade of postoperative complications

  Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.

  Postoperative 30 days

• Nipple necrosis rates

  Nipple necrosis rates are calculated as number of total nipple necrosis cases per total operation cases.

  Postoperative 30 days

• Recurrence free survival (RFS)

  Events of RFS includes locoregional recurrence, distant recurrence, and death. Contralateral breast cancer and second primary malignancy are considered to be censored data.

  Postoperative 5 years

Secondary Outcomes (2)

• Operation times

  Time during operation

• Locoregional recurrence-free survival (LRFS)

  Postoperative 5 years

Study Arms (2)

Robotic nipple sparing mastectomy group/RNSM

Cases or Patients who underwent robotic nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Robotic nipple-sparing mastectomy should be performed using robotic surgical systems. Robotic surgical systems include da Vinci S,Si, X, Xi, and SP systems. Axillary or lateral incisions are used for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with robotic mastectomy without immediate reconstruction are excluded. The estimated sample size for this arm is 300 cases.

Procedure: Robotic nipple sparing mastectomy

Conventional nipple sparing mastectomy group/CNSM

Cases or Patients who underwent conventional nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Conventional nipple-sparing mastectomy should not be performed using robotic or endoscopic surgical systems. Axillary or lateral incisions that are similar to incisions in robotic nipple-sparing mastectomy are not allowed. Other than axillary or lateral incisions can be performed for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with nipple-sparing mastectomy without immediate reconstruction are excluded. The estimated sample size for this arm is 300 cases.

Interventions

Robotic nipple sparing mastectomy PROCEDURE

Robotic nipple sparing mastectomy means nipple sparing mastectomy performed using robotic surgical systems.

Also known as: Robot-assisted nipple sparing mastectomy, Robot mastectomy, Robotic mastectomy, Hybrid robotic nipple sparing mastectomy, Robot-assisted nipple areolar complex and skin sparing mastectomy

Robotic nipple sparing mastectomy group/RNSM

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent nipple-sparing mastectomy between 2016 and 2020 at Severance Hospital, Seoul, Korea. Patients who underwent nipple-sparing mastectomy between 2016 and 2020 at Samsung Medical Center, Seoul, Korea. Patients who underwent nipple sparing mastectomy between 2014 and 2019 at European Institute of Oncology, Milan, Italy. Patients who underwent nipple-sparing mastectomy between 2017 and 2019 at Changhua Christian Hospital, Changhua City, Taiwan. Patients who underwent nipple-sparing mastectomy between 2015 and 2019 at Gustave Roussy, Paris, France.

You may qualify if:

• Women who underwent nipple sparing mastectomy and immediate reconstruction
• Women with early breast cancer
• Women with germline BRCA 1/2 mutation or germline mutations in genetic susceptibility genes
• Women with interstitial mastopathy
• Women with risk-reducing mastectomy or contralateral mastectomy

You may not qualify if:

• Male patients
• Women with stage IV disease at diagnosis
• Women who underwent previous breast cancer surgery
• Women who received prior radiotherapy for the ipsilateral breast

Sponsors & Collaborators

• Severance Hospital: lead
• European Institute of Oncology: collaborator
• Changhua Christian Hospital: collaborator
• Samsung Medical Center: collaborator

Study Sites (1)

Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (16)

• 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 BACKGROUND

• Park HS, Kim JH, Lee DW, Song SY, Park S, Kim SI, Ryu DH, Cho YU. Gasless Robot-Assisted Nipple-Sparing Mastectomy: A Case Report. J Breast Cancer. 2018 Sep;21(3):334-338. doi: 10.4048/jbc.2018.21.e45. Epub 2018 Sep 20.

  PMID: 30275863 BACKGROUND

• Galimberti V, Morigi C, Bagnardi V, Corso G, Vicini E, Fontana SKR, Naninato P, Ratini S, Magnoni F, Toesca A, Kouloura A, Rietjens M, De Lorenzi F, Vingiani A, Veronesi P. Oncological Outcomes of Nipple-Sparing Mastectomy: A Single-Center Experience of 1989 Patients. Ann Surg Oncol. 2018 Dec;25(13):3849-3857. doi: 10.1245/s10434-018-6759-0. Epub 2018 Sep 17.

  PMID: 30225833 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

• Toesca A, Peradze N, Manconi A, Nevola Teixeira LF. Reply to the letter to the editor "Robotic-assisted Nipple Sparing Mastectomy: A feasibility study on cadaveric models" by Sarfati B. et al. J Plast Reconstr Aesthet Surg. 2017 Apr;70(4):558-560. doi: 10.1016/j.bjps.2016.12.022. Epub 2017 Jan 23. No abstract available.

  PMID: 28153430 BACKGROUND

• 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.

  PMID: 30360987 BACKGROUND

• Lai HW, Lin SL, Chen ST, Chen SL, Lin YL, Chen DR, Kuo SJ. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction with Gel Implant. Plast Reconstr Surg Glob Open. 2018 Jun 11;6(6):e1828. doi: 10.1097/GOX.0000000000001828. eCollection 2018 Jun.

  PMID: 30276055 BACKGROUND

• Lai HW. Robotic Nipple-Sparing Mastectomy and Immediate Breast Reconstruction with Gel Implant. Ann Surg Oncol. 2019 Jan;26(1):53-54. doi: 10.1245/s10434-018-6711-3. Epub 2018 Aug 25. No abstract available.

  PMID: 30145648 BACKGROUND

• Lai HW, Lin SL, Chen ST, Lin YL, Chen DR, Pai SS, Kuo SJ. Robotic nipple sparing mastectomy and immediate breast reconstruction with robotic latissimus dorsi flap harvest - Technique and preliminary results. J Plast Reconstr Aesthet Surg. 2018 Oct;71(10):e59-e61. doi: 10.1016/j.bjps.2018.07.006. Epub 2018 Aug 2. No abstract available.

  PMID: 30122600 BACKGROUND

• 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.

  PMID: 30109537 BACKGROUND

• Lai HW, Chen ST, Lin SL, Lin YL, Wu HK, Pai SH, Chen DR, Kuo SJ. Technique for single axillary incision robotic assisted quadrantectomy and immediate partial breast reconstruction with robotic latissimus dorsi flap harvest for breast cancer: A case report. Medicine (Baltimore). 2018 Jul;97(27):e11373. doi: 10.1097/MD.0000000000011373.

  PMID: 29979425 BACKGROUND

• 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 BACKGROUND

• Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Kolb F, Rimareix F. Robotic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: Surgical Technique. Plast Reconstr Surg. 2018 Sep;142(3):624-627. doi: 10.1097/PRS.0000000000004703.

  PMID: 29879007 BACKGROUND

• Sarfati B, Honart JF, Leymarie N, Rimareix F, Al Khashnam H, Kolb F. Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. Breast J. 2018 May;24(3):373-376. doi: 10.1111/tbj.12937. Epub 2017 Dec 18.

  PMID: 29251382 BACKGROUND

• Sarfati B, Honart JF, Leymarie N, Kolb F, Rimareix F. Robotic-assisted Nipple Sparing Mastectomy: A feasibility study on cadaveric models. J Plast Reconstr Aesthet Surg. 2016 Nov;69(11):1571-1572. doi: 10.1016/j.bjps.2016.08.007. Epub 2016 Sep 8. No abstract available.

  PMID: 27665275 BACKGROUND

• Park HS, Lee J, Lai HW, Park JM, Ryu JM, Lee JE, Kim JY, Marrazzo E, De Scalzi AM, Corso G, Montemurro F, Gazzetta G, Pozzi G, Toesca A. Surgical and Oncologic Outcomes of Robotic and Conventional Nipple-Sparing Mastectomy with Immediate Reconstruction: International Multicenter Pooled Data Analysis. Ann Surg Oncol. 2022 Oct;29(11):6646-6657. doi: 10.1245/s10434-022-11865-x. Epub 2022 May 18.

  PMID: 35583693 RESULT

MeSH Terms

Conditions

Postoperative Complications; Recurrence; Breast Neoplasms

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Hyung Seok Park, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

• Antonio Toesca, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 27, 2019
• Study Start: May 14, 2020
• Primary Completion: May 4, 2022
• Study Completion: May 18, 2022
• Last Updated: September 11, 2023

Record last verified: 2023-09

Locations

KR (1)