Clinical trial · Interventional
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer-Prospective Study
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer- A Prospective Registry Case Control Study
NCT04037852CI-TRIAL-00053856RCENSM-PunknownN/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)
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.
Conditions
Conditions (1)
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional nipple sparing mastectomy | Procedure | — | UNRESOLVED |
| Endoscopic assisted nipple sparing mastectomy | Procedure | — | UNRESOLVED |
| robotic assisted nipple sparing mastectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Robotic assisted nipple sparing mastectomy (R-NSM)
- description
- R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM.
- interventionNames
- Device: robotic assisted nipple sparing mastectomy
- type
- ACTIVE_COMPARATOR
- label
- Conventional nipple sparing mastectomy (C-NSM)
- description
- Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy.
- interventionNames
- Procedure: Conventional nipple sparing mastectomy
- type
- ACTIVE_COMPARATOR
- label
- Endoscopic assisted nipple sparing mastectomy (E-NSM)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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) * 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. Exclusion Criteria: * \- 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.
References
Publications (15)
- BACKGROUNDPetit 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. PMID 16226028
- BACKGROUNDLeff 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
- BACKGROUNDTukenmez 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
- BACKGROUNDToesca 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
- BACKGROUNDMoran 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. PMID 24515565
- BACKGROUNDPark 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.