Clinical trial · Interventional
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
NCT03838549CI-TRIAL-00109417MRIMOPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Genetic Predisposition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic mastectomy with immediate breast reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- implant for breast reconstruction
- description
- 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
- interventionNames
- Procedure: Prophylactic mastectomy with immediate breast reconstruction
Primary outcomes (1)
- measure
- success rate of total mastectomy
- timeFrame
- one day
- description
- 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
Secondary outcomes (17)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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)
References
Publications (27)
- BACKGROUNDJakub 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
- BACKGROUNDColwell 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
- BACKGROUNDMuller 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
- BACKGROUNDCasella 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
- BACKGROUNDMiyake 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
- BACKGROUNDCo 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
- 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.