Clinical trial · Interventional

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

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

NCT01969448CI-TRIAL-00032567NASSMcompletedN/AResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (3)

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
Ductal Carcinoma in Situ - Category	Breast Neoplasm	PROBABILISTIC	0.70
Prophylactic Mastectomy	—	UNRESOLVED	—

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
Indocyanine Green	Drug	—	UNRESOLVED
Inframammary Fold Incision	Procedure	—	UNRESOLVED
Inframammary Fold Incision or Lateral Radial Incision	Procedure	—	UNRESOLVED
Laser-assisted fluorescence angiography	Device	—	UNRESOLVED
Lateral Radial Incision	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (3)

type
ACTIVE_COMPARATOR
label
Inframammary Fold Incision Cohort
description
* Inframammary fold incision which is in the crease under the breast. * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)
interventionNames
1. Procedure: Inframammary Fold Incision
2. Device: Laser-assisted fluorescence angiography
3. Drug: Indocyanine Green
type
ACTIVE_COMPARATOR
label
Lateral Radial Incision Cohort
description
* Lateral radial incision * Perfusion of the involved breast will be monitored at three separate time points using laser-assisted fluorescence angiography (Spy Elite, LifeCell) * Intraoperatively prior to mastectomy * At the conclusion of NASSM (following completion of mastectomy procedure and prior to implant insertion during reconstruction) - (ie. Mastectomy done, implant not in yet) * Following the conclusion of reconstruction with an immediate implant and skin closure with either temporary staples or final suture placement (ie. Mastectomy done and implant in)

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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.

References

Publications (18)

BACKGROUNDKim 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. PMID 20134317
BACKGROUNDCense 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. doi: 10.1053/ejso.2001.1130. PMID 11520082
BACKGROUNDPaepke 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. PMID 19638905
BACKGROUNDde 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. PMID 21847697
BACKGROUNDSalzberg 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):514-524. doi: 10.1097/PRS.0b013e318200a961. PMID 21285756
BACKGROUNDSacchini 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. doi: 10.1016/j.jamcollsurg.2006.07.015. Epub 2006 Sep 11. PMID 17084333

Registry

Dates and enrollment

Start: Mar 28, 2013
Primary completion: Apr 27, 2016
Completion: Apr 17, 2017
First posted: Oct 25, 2013
Last update posted: Apr 18, 2018
Results first posted: Apr 18, 2018
Enrollment: 79 (actual)
Lead sponsor: Washington University School of Medicine OTHER
Collaborators: LifeCell
Keywords: Nipple-areola skin sparing mastectomy, Immediate reconstruction, Prophylactic Mastectomy, Breast-Q, Breast Cancer, Ductal Carcinoma in Situ - Category

Data updated 22 days agoSource updated Apr 18, 2018source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.