Status:
ACTIVE_NOT_RECRUITING
Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy
Lead Sponsor:
Guangdong Provincial People's Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
The goal of this clinical study is to explore whether preoperative application of 3D reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after...
Detailed Description
The 3D reconstruction tool was applied preoperatively to assess the blood supply and volume of participants' breasts and to recommend personalized prosthesis volume. Compared with electrosurgical knif...
Eligibility Criteria
Inclusion
- Pathologically confirmed diagnosis of breast cancer
- Age: 18 to 70 years old
- No infiltration of the nipple-areola complex and negative histopathology of the nipple basal margins;
- Participants who meet the indications for breast conserving surgery require total mastectomy and reconstruction;
Exclusion
- Inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy;
- Participants with clinical or imaging evidence of preoperative involvement of the nipple/areolar region, including Paget's disease, nipple spillage, inflammatory breast cancer, and/or imaging findings suggesting malignant involvement of the nipple or subareolar tissues, according to the 2023 NCCN guideline recommendations, where retaining the NAC fails to yield negative margins;
Key Trial Info
Start Date :
October 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT06071234
Start Date
October 8 2023
End Date
December 30 2025
Last Update
January 23 2025
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080