Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy (NCT06071234) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy
China126 participantsStarted 2023-10-08
Plain-language 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 surgery.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion Criteria:
* 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 Criteria:
* 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;
What they're measuring
1
Ischemic complications of flap and nipple areola complex