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

NCT03105570 | Unknown

• 1 other identifier: ASM-China
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Keywords

breast neoplasms; Mastectomy, Subcutaneous; Areola

Outcome Measures

Primary Outcomes (1)

• Recurrence of areolar area

  The frequency of histologically confirmed recurrence on the preserved pigmented areolar area.

  Five years after initial surgery

Secondary Outcomes (3)

• Cosmetic effect of reconstructed breast

  2-4 weeks after surgery; 2 years and 5 years after surgery.

• Adverse effect of surgery

  4 weeks after surgery.

• Disease free survival

  5 year after surgery

Study Arms (1)

Areola sparing mastectomy.

EXPERIMENTAL

Eligible patients undergo areola sparing mastectomy.

Procedure: Areola Sparing Mastectomy

Interventions

Areola Sparing Mastectomy 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.

Also known as: Nipple coring

Areola sparing mastectomy.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed invasive or in situ breast cancer.
• cTis-2N0-1M0.
• Indicated for total mastectomy and desire immediate breast reconstruction.

You may not qualify if:

• cT3-4 or cN2-N3 breast cancer.
• Retraction of nipple or areola.
• Involvement of subcutaneous layer by cancer on ultrasound or MRI.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 10044, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shu Wang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Houpu Yang, MD

CONTACT

88324010; yanghoupu@pkuph.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single Armed, prospective, open label study

Study Record Dates

• First Submitted: April 4, 2017
• First Posted: April 10, 2017
• Study Start: May 1, 2017
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: October 17, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)