Back to resultsThe Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
Primary Purpose
Breast Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Areola Sparing Mastectomy
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring breast neoplasms, Mastectomy, Subcutaneous, Areola
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.
Sites / Locations
- Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Areola sparing mastectomy.
Arm Description
Eligible patients undergo areola sparing mastectomy.
Outcomes
Primary Outcome Measures
Recurrence of areolar area
The frequency of histologically confirmed recurrence on the preserved pigmented areolar area.
Secondary Outcome Measures
Cosmetic effect of reconstructed breast
The cosmetic results evaluated by a surgeon and a nurse through reviewing photographs.
Adverse effect of surgery
Wound dehiscence, infection, suture exposure and extrusion.
Disease free survival
Survival time to any recurrence and any cause death.
Full Information
NCT ID
NCT03105570
First Posted
April 4, 2017
Last Updated
October 14, 2022
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03105570
Brief Title
The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
Official Title
The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
breast neoplasms, Mastectomy, Subcutaneous, Areola
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Armed, prospective, open label study
Masking
None (Open Label)
Allocation
N/A
Enrollment
145 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Areola sparing mastectomy.
Arm Type
Experimental
Arm Description
Eligible patients undergo areola sparing mastectomy.
Intervention Type
Procedure
Intervention Name(s)
Areola Sparing Mastectomy
Other Intervention Name(s)
Nipple coring
Intervention Description
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.
Primary Outcome Measure Information:
Title
Recurrence of areolar area
Description
The frequency of histologically confirmed recurrence on the preserved pigmented areolar area.
Time Frame
Five years after initial surgery
Secondary Outcome Measure Information:
Title
Cosmetic effect of reconstructed breast
Description
The cosmetic results evaluated by a surgeon and a nurse through reviewing photographs.
Time Frame
2-4 weeks after surgery; 2 years and 5 years after surgery.
Title
Adverse effect of surgery
Description
Wound dehiscence, infection, suture exposure and extrusion.
Time Frame
4 weeks after surgery.
Title
Disease free survival
Description
Survival time to any recurrence and any cause death.
Time Frame
5 year after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Houpu Yang, MD
Phone
88324010
Email
yanghoupu@pkuph.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shu Wang, MD
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
10044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Houpu Yang, MD
Phone
010-88324010
Email
yanghoupu@pkuph.edu.cn
First Name & Middle Initial & Last Name & Degree
Shu Wang, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
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