Nipple Sparing Mastectomy - Cosmetic Outcomes

Breast Cancer Clinical Trial

Official title:

Preservation of the Nipple Areolar Complex With Skin Sparing Mastectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002014
• Other study ID #: LCI NAC-SSM
• Status: Completed
• Phase: N/A
• Start date: January 21, 2009
• Est. completion date: September 20, 2018

Study information

• Verified date: January 2019
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to observe the cosmetic outcomes, patient satisfaction, and complications after skin sparing mastectomy with preservation of the nipple areolar complex.

Description:

The outcomes will be observed in patients with both known cancer diagnosis and in those with indications for prophylactic mastectomy. The cosmetic appearance and complications will be followed through several post operative visits throughout the duration of the study. This study is conducted in conjunction with the plastic and reconstructive surgeons who will be performing the breast reconstruction procedures. Patient satisfaction will be measured via survey format. In addition, local recurrence rates will be compared to patients undergoing traditional mastectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 20, 2018
• Est. primary completion date: August 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients requiring mastectomy for cancer and/or prophylaxis
• Age greater than or equal to 18 at time of surgery
• BMI less than or equal to 35
• If mastectomy is indicated for removal of breast cancer, tumor is clinically T1 or T2

Exclusion Criteria:

• Currently smoking
• Prior radiation to the affected breast
• Systemic lupus erythematosus
• Central tumor location and/or tumor within 2 cm of NAC
• Paget's disease of the nipple
• Clinical evidence of tumor involvement in the nipple
• Clinical evidence of axillary nodal tumor involvement
• Lymphovascular invasion of the tumor on core biopsy

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Breast Reconstruction
• Cosmesis

Intervention

Procedure:
• Nipple Sparing Mastectomy
Skin sparing mastectomy with preservation of the nipple areolar complex

Locations

Country	Name	City	State
United States	Levine Cancer Institute	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (13)

Banerjee A, Gupta S, Bhattacharya N. Preservation of nipple-areola complex in breast cancer--a clinicopathological assessment. J Plast Reconstr Aesthet Surg. 2008 Oct;61(10):1195-8. Epub 2007 Sep 27. — View Citation

Carlson GW, Losken A, Moore B, Thornton J, Elliott M, Bolitho G, Denson DD. Results of immediate breast reconstruction after skin-sparing mastectomy. Ann Plast Surg. 2001 Mar;46(3):222-8. — View Citation

Crowe JP Jr, Kim JA, Yetman R, Banbury J, Patrick RJ, Baynes D. Nipple-sparing mastectomy: technique and results of 54 procedures. Arch Surg. 2004 Feb;139(2):148-50. — View Citation

Crowe JP, Patrick RJ, Yetman RJ, Djohan R. Nipple-sparing mastectomy update: one hundred forty-nine procedures and clinical outcomes. Arch Surg. 2008 Nov;143(11):1106-10; discussion 1110. doi: 10.1001/archsurg.143.11.1106. — View Citation

Fitzal F. Can nipple-sparing mastectomy and immediate breast reconstruction with modified extended latissimus dorsi muscular flap improve the cosmetic and functional outcome of patients with breast cancer? World J Surg. 2008 Mar;32(3):499; author reply 500-1. — View Citation

Gerber B, Krause A, Reimer T, Müller H, Küchenmeister I, Makovitzky J, Kundt G, Friese K. Skin-sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction is an oncologically safe procedure. Ann Surg. 2003 Jul;238(1):120-7. — View Citation

Laronga C, Kemp B, Johnston D, Robb GL, Singletary SE. The incidence of occult nipple-areola complex involvement in breast cancer patients receiving a skin-sparing mastectomy. Ann Surg Oncol. 1999 Sep;6(6):609-13. — View Citation

Loewen MJ, Jennings JA, Sherman SR, Slaikeu J, Ebrom PA, Davis AT, Fitzgerald TL. Mammographic distance as a predictor of nipple-areola complex involvement in breast cancer. Am J Surg. 2008 Mar;195(3):391-4; discussion 394-5. doi: 10.1016/j.amjsurg.2007.12.020. — View Citation

Lowery JC, Wilkins EG, Kuzon WM, Davis JA. Evaluations of aesthetic results in breast reconstruction: an analysis of reliability. Ann Plast Surg. 1996 Jun;36(6):601-6; discussion 607. — View Citation

Sacchini V, Pinotti JA, Barros AC, Luini A, Pluchinotta A, Pinotti M, Boratto MG, Ricci MD, Ruiz CA, Nisida AC, Veronesi P, Petit J, Arnone P, Bassi F, Disa JJ, Garcia-Etienne CA, Borgen PI. Nipple-sparing mastectomy for breast cancer and risk reduction: oncologic or technical problem? J Am Coll Surg. 2006 Nov;203(5):704-14. Epub 2006 Sep 11. — View Citation

Stolier AJ, Sullivan SK, Dellacroce FJ. Technical considerations in nipple-sparing mastectomy: 82 consecutive cases without necrosis. Ann Surg Oncol. 2008 May;15(5):1341-7. doi: 10.1245/s10434-007-9753-5. Epub 2008 Feb 7. — View Citation

Vlajcic Z, Zic R, Stanec S, Lambasa S, Petrovecki M, Stanec Z. Nipple-areola complex preservation: predictive factors of neoplastic nipple-areola complex invasion. Ann Plast Surg. 2005 Sep;55(3):240-4. — View Citation

Wijayanayagam A, Kumar AS, Foster RD, Esserman LJ. Optimizing the total skin-sparing mastectomy. Arch Surg. 2008 Jan;143(1):38-45; discussion 45. doi: 10.1001/archsurg.143.1.38. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cosmetic Appearance		First Post Operative year
Primary	Patient Satisfaction		First Post Operative Year
Primary	Presence of tumor in nipple areolar complex frozen section		Duration of Study
Primary	Presence of tumor in nipple areolar complex permanent histology		Duration of study
Secondary	Complications		First Post Operative year
Secondary	Local Recurrence		One year