The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study

Study Overview
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Brief Summary
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To balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the oncological safety of nipple sparing mastectomy a controversial issue. Since the involvement of areolar pigmented skin by cancer is rare compared to that of nipple, we designed the current study to investigate the oncological safety and cosmetic outcome of Areola Sparing Mastectomy.

Detailed Description
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Primary breast cancer originated from areolae is rare. We hypothesized that nipple and areola are two separate anatomy tissue and have different oncological impact on the treatment of breast cancer. Areola Sparing Mastectomy (ASM) is a innovative procedure that involves of removal of nipple and preservation of areola the pigmented skin of which would improve the cosmetic outcome of mastectomy and lead to a illusion of congenital crater nipple in some patients.

Official Title
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The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Procedure: Areola Sparing Mastectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed invasive or in situ breast cancer. cTis-2N0-1M0. Indicated for total mastectomy and desire immediate breast reconstruction. Exclusion Criteria: cT3-4 or cN2-N3 breast cancer. Retraction of nipple or areola. Involvement of subcutaneous layer by cancer on ultrasound or MRI.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Single Armed, prospective, open label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Areola sparing mastectomy.<br>Eligible patients undergo areola sparing mastectomy. | Procedure: Areola Sparing Mastectomy<br>* A small circular incision would be made to separate nipple from breast and an additional incision directly extended from nipple or located at other part of breast such as infra-mammary fold and subaxillary area would be made to remove the total mammary parenchyma. Routine implant based or flap base reconstruction would be performed subsequentially. Nipple reconstruction is optional.<br>* Other names: Nipple coring;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence of areolar area | The frequency of histologically confirmed recurrence on the preserved pigmented areolar area. | Five years after initial surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cosmetic effect of reconstructed breast | The cosmetic results evaluated by a surgeon and a nurse through reviewing photographs. | 2-4 weeks after surgery; 2 years and 5 years after surgery. | 
| Adverse effect of surgery | Wound dehiscence, infection, suture exposure and extrusion. | 4 weeks after surgery. | 
| Disease free survival | Survival time to any recurrence and any cause death. | 5 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast neoplasms, Mastectomy, Subcutaneous, Areola