Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

Breast Cancer Clinical Trial

— NASSM  

Official title:

A Prospective Randomized Trial to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01969448
• Other study ID #: 201302004
• Status: Completed
• Phase: N/A
• First received: October 14, 2013
• Last updated: March 20, 2018
• Start date: March 28, 2013
• Est. completion date: April 17, 2017

Study information

• Verified date: March 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision. Moreover, by minimizing complications and optimizing aesthetic outcomes, the investigators believe it will be associated with significantly higher patient reported outcome scores. The addition of information gained by use of intraoperative laser-assisted fluorescent angiography (measured with the Spy Elite imaging device) will reduce complication rates by directing intraoperative resection of ischemic tissue and limiting the volume of immediate implant placement in instances where real time imaging would suggest compromised perfusion. These quantifiable, objective measures will justify the use of NASSM and immediate implant placement coupled with intraoperative laser-assisted fluorescent angiography in prosthetic based breast reconstruction despite longer operative times.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: April 17, 2017
• Est. primary completion date: April 27, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient must be scheduled to undergo either a single or bilateral elective nipple-areola skin sparing mastectomy (NASSM) procedure with planned immediate reconstruction.

• Patient must be 18 years of age or older.

• Karnofsky Performance Scale of at least 80%.

• Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

• Cognitive impairment.

• BMI < 18 or > 35

• Breast >800 grams or <100 grams in predicted weight. "Breast" includes the breast tissue and in cases where the patient already has cosmetic breast implants, the additional breast implant mass. The sum total must be >100 g and <800 g.

• History of radiation to the chest wall or breast being studied

• Patients who have a history of allergy to iodides or iodinated contrast agents

• Surgeon's opinion at the time of surgery that the subject's well-being would be compromised (e.g. significant comorbidities, intraoperative findings of a higher stage cancer or other independent acute health problems). If the contralateral breast is undergoing a nipple-sparing mastectomy with reconstruction as well, then the contralateral breast can be studied so long as there is no compromise to any element of their care.

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Carcinoma in Situ - Category
• Prophylactic Mastectomy

Intervention

Procedure:
• Inframammary Fold Incision or Lateral Radial Incision

• Lateral Radial Incision

• Inframammary Fold Incision

Device:
• Laser-assisted fluorescence angiography

Drug:
• Indocyanine Green

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	LifeCell

Country where clinical trial is conducted

United States, 

References & Publications (17)

Ashikari RH, Ashikari AY, Kelemen PR, Salzberg CA. Subcutaneous mastectomy and immediate reconstruction for prevention of breast cancer for high-risk patients. Breast Cancer. 2008;15(3):185-91. doi: 10.1007/s12282-008-0059-7. — View Citation

Ashitate Y, Lee BT, Ngo LH, Laurence RG, Hutteman M, Oketokoun R, Lunsford E, Soo Choi H, Frangioni JV. Quantitative assessment of nipple perfusion with near-infrared fluorescence imaging. Ann Plast Surg. 2013 Feb;70(2):149-53. doi: 10.1097/SAP.0b013e31822f9af7. — View Citation

Cense HA, Rutgers EJ, Lopes Cardozo M, Van Lanschot JJ. Nipple-sparing mastectomy in breast cancer: a viable option? Eur J Surg Oncol. 2001 Sep;27(6):521-6. Review. — View Citation

de Alcantara Filho P, Capko D, Barry JM, Morrow M, Pusic A, Sacchini VS. Nipple-sparing mastectomy for breast cancer and risk-reducing surgery: the Memorial Sloan-Kettering Cancer Center experience. Ann Surg Oncol. 2011 Oct;18(11):3117-22. doi: 10.1245/s10434-011-1974-y. Epub 2011 Aug 17. — View Citation

Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149. — View Citation

Garwood ER, Moore D, Ewing C, Hwang ES, Alvarado M, Foster RD, Esserman LJ. Total skin-sparing mastectomy: complications and local recurrence rates in 2 cohorts of patients. Ann Surg. 2009 Jan;249(1):26-32. doi: 10.1097/SLA.0b013e31818e41a7. — View Citation

Gerber B, Krause A, Dieterich M, Kundt G, Reimer T. The oncological safety of skin sparing mastectomy with conservation of the nipple-areola complex and autologous reconstruction: an extended follow-up study. Ann Surg. 2009 Mar;249(3):461-8. doi: 10.1097/SLA.0b013e31819a044f. — 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

Kim HJ, Park EH, Lim WS, Seo JY, Koh BS, Lee TJ, Eom JS, Lee SW, Son BH, Lee JW, Ahn SH. Nipple areola skin-sparing mastectomy with immediate transverse rectus abdominis musculocutaneous flap reconstruction is an oncologically safe procedure: a single center study. Ann Surg. 2010 Mar;251(3):493-8. doi: 10.1097/SLA.0b013e3181c5dc4e. — View Citation

Komorowska-Timek E, Gurtner GC. Intraoperative perfusion mapping with laser-assisted indocyanine green imaging can predict and prevent complications in immediate breast reconstruction. Plast Reconstr Surg. 2010 Apr;125(4):1065-73. doi: 10.1097/PRS.0b013e3181d17f80. — View Citation

Lista F, Ahmad J. Vertical scar reduction mammaplasty: a 15-year experience including a review of 250 consecutive cases. Plast Reconstr Surg. 2006 Jun;117(7):2152-65; discussion 2166-9. — View Citation

Losken A, Zenn MR, Hammel JA, Walsh MW, Carlson GW. Assessment of zonal perfusion using intraoperative angiography during abdominal flap breast reconstruction. Plast Reconstr Surg. 2012 Apr;129(4):618e-24e. doi: 10.1097/PRS.0b013e3182450b16. — View Citation

Paepke S, Schmid R, Fleckner S, Paepke D, Niemeyer M, Schmalfeldt B, Jacobs VR, Kiechle M. Subcutaneous mastectomy with conservation of the nipple-areola skin: broadening the indications. Ann Surg. 2009 Aug;250(2):288-92. doi: 10.1097/SLA.0b013e3181b0c7d8. — View Citation

Palmieri B, Baitchev G, Grappolini S, Costa A, Benuzzi G. Delayed nipple-sparing modified subcutaneous mastectomy: rationale and technique. Breast J. 2005 May-Jun;11(3):173-8. — 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

Salzberg CA, Ashikari AY, Koch RM, Chabner-Thompson E. An 8-year experience of direct-to-implant immediate breast reconstruction using human acellular dermal matrix (AlloDerm). Plast Reconstr Surg. 2011 Feb;127(2):514-24. doi: 10.1097/PRS.0b013e318200a961. — View Citation

Tepper OM, Karp NS, Small K, Unger J, Rudolph L, Pritchard A, Choi M. Three-dimensional imaging provides valuable clinical data to aid in unilateral tissue expander-implant breast reconstruction. Breast J. 2008 Nov-Dec;14(6):543-50. doi: 10.1111/j.1524-4741.2008.00645.x. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Original Preoperative Blood Supply (Perfusion) Post Nipple Sparing Mastectomy	Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion.; The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds).	At the time of surgery (day 1)
Primary	Percentage of Original Preoperative Blood Supply (Perfusion) Post Reconstruction	Laser-assisted fluorescent angiography via the Spy Elite imaging device will be utilized to capture this data during mastectomy and immediate breast reconstruction. Standard postoperative patient follow up will assess for perfusion.; The Spy device quantifies perfusion by measuring relative fluorescence of indocyanine green bound to plasma proteins. This produces an intensity value of 0-255 based on an 8-bit greyscale. The investigators measured this value preoperatively when measured and compared to the post-intervention measurement. The device can calculate the cumulative intensity of a defined region of interest which the investigators categorized as the lateral, lower, medial, or nipple-areola region of the breast. The investigators also evaluated the cumulative value of these areas in total. Rate of perfusion was simply this value over time (90 seconds).	At the time of surgery (day 1)
Secondary	Breast Q Score	-The BREAST-Q is a previously validated instrument which measures patient reported outcomes. It has several iterations including the one utilized here which is specific for implant-based breast reconstruction. Each of its 6 domains generates a Q-score from 0 (lowest) to 100 (highest). A higher number indicates a higher satisfaction or better quality of life than a lower number. Based on answers to the questions, each individual will generate a whole number score for each domain. The patient can be sampled preoperatively and postoperatively as well as over time to calculate the impact of intervention and time on this value. Q-scores are calculated for each domain, and the investigators report a mean value based on data from an entire cohort for the particular domain. Domains include evaluation of overall satisfaction with breasts, physical well being, sexual well being, as well as satisfaction with office staff, information provided, and the provider.	Up to 3 months post permanent implant placement
Secondary	Number of Participants With Tissue Expander		Up to 3 months post permanent implant placement
Secondary	Mean Operative Times for Mastectomy		At the time of surgery (day 1)
Secondary	Breast Weight		At time of surgery (day 1)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine