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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03105570
• Other study ID #: ASM-China
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: May 1, 2024

Study information

• Verified date: October 2022
• Source: Peking University People's Hospital
• Contact: Houpu Yang, MD
• Phone: 88324010
• Email: yanghoupu[@]pkuph.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 145
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• Areola 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.

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of areolar area	The frequency of histologically confirmed recurrence on the preserved pigmented areolar area.	Five years after initial surgery
Secondary	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.
Secondary	Adverse effect of surgery	Wound dehiscence, infection, suture exposure and extrusion.	4 weeks after surgery.
Secondary	Disease free survival	Survival time to any recurrence and any cause death.	5 year after surgery