Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication

NCT03838549 | Completed DMC

• 2 other identifiers: RECHMPL18_0244UF 7672
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume. Current techniques involve partial or total coverage of the implant with the pectoralis major muscle, to prevent exposure or infection. The muscle dissection technique applied has functional and cosmetic consequences. In this study, an endoscopic approach will be evaluated. This new surgical technique, using a single-port endoscopic way, will put the scar is in the axillary area, away from the breast. The hypothesis is that this delocalized scar potentially reduces the risk of exposure and allows placement of the implant in the subcutaneous space, with no manipulation of the pectoralis major muscle.

Conditions

Breast Cancer; Genetic Predisposition

Keywords

Prophylactic Surgical Procedure; Subcutaneous Mastectomy; Endoscopy; Breast Reconstruction; Breast Implants

Outcome Measures

Primary Outcomes (1)

• success rate of total mastectomy

  The total mastectomy is done by a scar in the axillary area, away from the breast, using single port endoscopy, with Implant base reconstruction in pre pectoral position. Complete excision of the gland by means of an incision on the axillary line, Installation of a definitive smooth prosthesis, Absence of conversion to a conventional approach, No skin necrosis

  one day

Secondary Outcomes (17)

• Operative time

  one day

• Open surgery conversion rate

  one day

• Number of participants with an infection

  1 and 3 months after the prophylactic mastectomy

• Blood loss

  one day

• Number of participants with a local haematoma

  Between the day of the prophylactic mastectomy and a month later

Study Arms (1)

implant for breast reconstruction

EXPERIMENTAL

20 patients female with genetic risk for breast cancer and who ask for prophylactic mastectomy. They will have a prophylactic mastectomy with immediate breast reconstruction

Procedure: Prophylactic mastectomy with immediate breast reconstruction

Interventions

Prophylactic mastectomy with immediate breast reconstruction PROCEDURE

It is an endoscopic approach for prophylactic mastectomy using an axillary single port

implant for breast reconstruction

Eligibility Criteria

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

You may qualify if:

• Patient with an indication for prophylactic uni or bilateral mastectomy (Genetic risk factors for breast cancer)
• Ask an immediate breast reconstruction during the surgery
• World Heath Organization score \<3
• Glandular volume : french bra cup size A, B ou C
• Glandular ptosis \<=2 (Classification and Algorithm for Treatment of Breast Ptosis)
• Contraception for woman of childbearing age and no pregnancy
• Valid Social Security
• Wrote consent

You may not qualify if:

• History of breast cancer surgery
• Breast cancer not operated on the side concerned by the prophylactic mastectomy
• Patient having had irradiant treatment
• Breast hypertrophy
• Smoking \> 10 cigarette/day
• Body Mass Index \> 30
• Large breast volume requiring prostheses \> 500ml
• Chronic pulmonary obstructive gold 4
• ASA (Physical Status score of American Society of Anesthesiologists) \> 3
• Chronic shoulder pain on the side to operate, or both shoulders
• History of abarticular pathology of the shoulder on the operating side
• Patient involvment in another clinical research
• Protected patient or unable to give consent
• Pregnant or breastfeeding woman
• Vulnerable person (Article L1121-6 of the Public Health Code)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Association la Montpellier Reine a du Cœur: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, Hérault, 34295, France

Location

Related Publications (27)

• Jakub JW, Peled AW, Gray RJ, Greenup RA, Kiluk JV, Sacchini V, McLaughlin SA, Tchou JC, Vierkant RA, Degnim AC, Willey S. Oncologic Safety of Prophylactic Nipple-Sparing Mastectomy in a Population With BRCA Mutations: A Multi-institutional Study. JAMA Surg. 2018 Feb 1;153(2):123-129. doi: 10.1001/jamasurg.2017.3422.

  PMID: 28903167 BACKGROUND

• Colwell AS, Christensen JM. Nipple-Sparing Mastectomy and Direct-to-Implant Breast Reconstruction. Plast Reconstr Surg. 2017 Nov;140(5S Advances in Breast Reconstruction):44S-50S. doi: 10.1097/PRS.0000000000003949.

  PMID: 29064921 BACKGROUND

• Muller T, Baratte A, Bruant-Rodier C, Bodin F, Mathelin C. Oncological safety of nipple-sparing prophylactic mastectomy: A review of the literature on 3716 cases. Ann Chir Plast Esthet. 2018 Jun;63(3):e6-e13. doi: 10.1016/j.anplas.2017.09.005. Epub 2017 Oct 10.

  PMID: 29030030 BACKGROUND

• Casella D, Di Taranto G, Marcasciano M, Sordi S, Kothari A, Kovacs T, Lo Torto F, Cigna E, Ribuffo D, Calabrese C. Nipple-sparing bilateral prophylactic mastectomy and immediate reconstruction with TiLoop(R) Bra mesh in BRCA1/2 mutation carriers: A prospective study of long-term and patient reported outcomes using the BREAST-Q. Breast. 2018 Jun;39:8-13. doi: 10.1016/j.breast.2018.02.001. Epub 2018 Feb 18.

  PMID: 29455110 BACKGROUND

• Miyake R, Kinoshita S, Shimada N, Uchida K, Takeyama H, Morikawa T. Preservation of the nipple-areola complex in skin-sparing mastectomy for early breast cancer. Surg Today. 2018 Jun;48(6):591-597. doi: 10.1007/s00595-018-1633-z. Epub 2018 Feb 21.

  PMID: 29468434 BACKGROUND

• Co M, Chiu R, Chiu TM, Chong YC, Lau S, Lee YH, To HM, Kwong A. Nipple-Sparing Mastectomy and Its Application on BRCA Gene Mutation Carrier. Clin Breast Cancer. 2017 Dec;17(8):581-584. doi: 10.1016/j.clbc.2017.02.001. Epub 2017 Feb 14.

  PMID: 28428099 BACKGROUND

• Ter Louw RP, Nahabedian MY. Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2017 Nov;140(5S Advances in Breast Reconstruction):51S-59S. doi: 10.1097/PRS.0000000000003942.

  PMID: 29064922 BACKGROUND

• Mitchell MP, Wagner J, Butterworth J. Subcutaneous implant-based breast reconstruction, a modern challenge in postmastectomy radiation planning. Pract Radiat Oncol. 2018 May-Jun;8(3):153-156. doi: 10.1016/j.prro.2017.09.001. Epub 2017 Sep 8.

  PMID: 29233522 BACKGROUND

• Sbitany H, Piper M, Lentz R. Prepectoral Breast Reconstruction: A Safe Alternative to Submuscular Prosthetic Reconstruction following Nipple-Sparing Mastectomy. Plast Reconstr Surg. 2017 Sep;140(3):432-443. doi: 10.1097/PRS.0000000000003627.

  PMID: 28574950 BACKGROUND

• Highton L, Johnson R, Kirwan C, Murphy J. Prepectoral Implant-Based Breast Reconstruction. Plast Reconstr Surg Glob Open. 2017 Sep 19;5(9):e1488. doi: 10.1097/GOX.0000000000001488. eCollection 2017 Sep.

  PMID: 29062655 BACKGROUND

• Heidemann LN, Gunnarsson GL, Salzberg CA, Sorensen JA, Thomsen JB. Complications following Nipple-Sparing Mastectomy and Immediate Acellular Dermal Matrix Implant-based Breast Reconstruction-A Systematic Review and Meta-analysis. Plast Reconstr Surg Glob Open. 2018 Jan 12;6(1):e1625. doi: 10.1097/GOX.0000000000001625. eCollection 2018 Jan.

  PMID: 29464161 BACKGROUND

• Glasberg SB. The Economics of Prepectoral Breast Reconstruction. Plast Reconstr Surg. 2017 Dec;140(6S Prepectoral Breast Reconstruction):49S-52S. doi: 10.1097/PRS.0000000000004051.

  PMID: 29166348 BACKGROUND

• Kompatscher P. Endoscopic capsulotomy of capsular contracture after breast augmentation: a very challenging therapeutic approach. Plast Reconstr Surg. 1992 Dec;90(6):1125-6. doi: 10.1097/00006534-199212000-00049. No abstract available.

  PMID: 1448521 BACKGROUND

• 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.

  PMID: 26950469 BACKGROUND

• Lai HW, Lin HY, Chen SL, Chen ST, Chen DR, Kuo SJ. Endoscopy-assisted surgery for the management of benign breast tumors: technique, learning curve, and patient-reported outcome from preliminary 323 procedures. World J Surg Oncol. 2017 Jan 11;15(1):19. doi: 10.1186/s12957-016-1080-5.

  PMID: 28077134 BACKGROUND

• 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 BACKGROUND

• Lai HW, Wu HS, Chuang KL, Chen DR, Chang TW, Kuo SJ, Chen ST, Kuo YL. Endoscopy-Assisted Total Mastectomy Followed by Immediate Pedicled Transverse Rectus Abdominis Musculocutaneous (TRAM) Flap Reconstruction: Preliminary Results of 48 Patients. Surg Innov. 2015 Aug;22(4):382-9. doi: 10.1177/1553350614546003. Epub 2014 Aug 12.

  PMID: 25118202 BACKGROUND

• 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.

  PMID: 21128113 BACKGROUND

• Wang Y, Wu JX, Guan S. A Technique of Endoscopic Nipple-Sparing Mastectomy for Breast Cancer. JSLS. 2017 Apr-Jun;21(2):e2017.00028. doi: 10.4293/JSLS.2017.00028.

  PMID: 28684896 BACKGROUND

• Ng TB, Lee HM, Cheng CH, Wong CC. Study on the purification of growth hormone-like substance from pituitaries of the snake Ptyas mucosa. Prep Biochem. 1993 Aug;23(3):351-61. doi: 10.1080/10826069308544561.

  PMID: 8361955 BACKGROUND

• 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

• 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

• 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

• Rathat G, Blay L, Bakenga J, Roggen N, Peralta G, Baekelandt J. Scarless preventive surgery. Int J Gynaecol Obstet. 2023 Nov;163(2):701-702. doi: 10.1002/ijgo.15039. Epub 2023 Aug 7. No abstract available.

  PMID: 37548070 RESULT

• Rathat G, Fontaine V, Chaumette M, Duraes M. [How I do... an endoscopic mastectomy in 10 steps]. Gynecol Obstet Fertil Senol. 2024 Nov;52(11):653-656. doi: 10.1016/j.gofs.2024.05.004. Epub 2024 May 29. No abstract available. French.

  PMID: 38821450 RESULT

• Rathat G, Chaumette M, Fontaine V, Rebel L, Pissarra J, Duflos C, Duraes M. Endoscopic prophylactic nipple-sparing mastectomy: First French survey of 10 patients. J Gynecol Obstet Hum Reprod. 2025 Jan;54(1):102862. doi: 10.1016/j.jogoh.2024.102862. Epub 2024 Oct 10.

  PMID: 39393530 RESULT

Related Links

• Institut national du cancer

MeSH Terms

Conditions

Genetic Predisposition to Disease; Breast Neoplasms

Interventions

Prophylactic Mastectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Prophylactic Surgical Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2019
• First Posted: February 12, 2019
• Study Start: April 26, 2019
• Primary Completion: September 26, 2025
• Study Completion: September 26, 2025
• Last Updated: April 24, 2026

Record last verified: 2025-12

Locations

FR (1)