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

NCT ID: NCT03105570

Last Updated: 2022-10-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2024-05-01

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Areola sparing mastectomy.

Eligible patients undergo areola sparing mastectomy.

Group Type: EXPERIMENTAL

Areola Sparing Mastectomy

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Nipple coring

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Houpu Yang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shu Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Houpu Yang, MD

Role: CONTACT

yanghoupu@pkuph.edu.cn

88324010

Facility Contacts

Houpu Yang, MD

Role: primary

yanghoupu@pkuph.edu.cn

010-88324010

Other Identifiers

ASM-China

Identifier Type: -

Identifier Source: org_study_id