Breast Neoplasms
Conditions
Keywords
breast neoplasms, Mastectomy, Subcutaneous, Areola
Brief summary
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
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.
Interventions
PROCEDUREAreola Sparing Mastectomy
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.
Sponsors
Peking University People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Armed, prospective, open label study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence of areolar area | Five years after initial surgery | The frequency of histologically confirmed recurrence on the preserved pigmented areolar area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic effect of reconstructed breast | 2-4 weeks after surgery; 2 years and 5 years after surgery. | The cosmetic results evaluated by a surgeon and a nurse through reviewing photographs. |
| Adverse effect of surgery | 4 weeks after surgery. | Wound dehiscence, infection, suture exposure and extrusion. |
| Disease free survival | 5 year after surgery | Survival time to any recurrence and any cause death. |
Countries
China
Contacts
Primary ContactHoupu Yang, MD
Outcome results
None listed