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Trial Title:
Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy
NCT ID:
NCT06071234
Condition:
Breast Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
3D reconstruction technology
Description:
Preoperative application of 3D reconstruction technology to evaluate the breast blood
supply of participants and observe whether the incidence of ischemic complications in the
flap and nipple areola complex is reduced compared to surgery without preoperative
evaluation.
Arm group label:
3D-reconstruction group
Arm group label:
Normal group
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.
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 knife separation，the flap was separated intraoperatively using a
combination of cold knife and electrosurgical knife to observe whether there was a
difference in the incidence of ischemic complications of participants' nipple areola
complex and flap, and whether the use of the 3D tool in the preoperative assessment was
effective in reducing the occurrence of postoperative ischemic complications.
Criteria for eligibility:
Criteria:
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;
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Start date:
October 8, 2023
Completion date:
December 30, 2025
Lead sponsor:
Agency:
Guangdong Provincial People's Hospital
Agency class:
Other
Source:
Guangdong Provincial People's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06071234
