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

Peking University

Status: Enrolling

Conditions: Breast Neoplasms

Treatments: Procedure: Areola Sparing Mastectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03105570

ASM-China

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 145 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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145 participants in 1 patient group

Areola sparing mastectomy.

Experimental group

Description:

Eligible patients undergo areola sparing mastectomy.

Treatment:

Procedure: Areola Sparing Mastectomy