An Exploration of 3D Printing Technology for Preoperative Evaluation in Reducing Ischemic Complications of Flap and Nipple-Areolar Complex (NAC) After Nipple-sparing Mastectomy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Guangdong Provincial People's Hospital
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Ischemic complications of flap and nipple areola complex
- Status
- Active, Not Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical study is to explore whether preoperative application of 3D printing technology to evaluate breast blood supply can improve the occurrence of ischemic complications in the flap and nipple areola complex after surgery.
Detailed Description
Preoperatively, 3D printing technology was applied to assess the blood supply of the breast, and intraoperatively, the flap was separated using a cold knife combined with an electrosurgical knife, and comparisons were made between the flap and the conventional electrosurgical knife to observe whether there was a difference in the incidence of ischemic complications in the nipple areola complex and the flap and whether the use of 3D printing technology in preoperative assessment was able to effectively reduce the occurrence of ischemic complications in the postoperative period.
Investigators
Kun Wang
Professor
Guangdong Provincial People's Hospital
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;
- •Patients 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;
- •Patients 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;
Outcomes
Primary Outcomes
Ischemic complications of flap and nipple areola complex
Time Frame: 1 week and 2 week after surgery
The incidence of ischemic complications in the skin flap and nipple areola complex after NSM surgery
Secondary Outcomes
- Severity of ischemic complications in the flap and nipple areola complex(1 week and 2 week after surgery)
- Duration of surgery(postoperative)
- Blood loss(Preoperative and 2 hours postoperatively)
- Breast-Q Satisfaction(Preoperative, 3 months and 1 year postoperatively)