Preoperative Evaluation of 3D Printing Technology for Nipple-sparing Mastectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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An Exploration of 3D Printing Technology for Preoperative Evaluation in Reducing Ischemic Complications of Flap and Nipple-Areolar Complex (NAC) After Nipple-sparing Mastectomy

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: 3D printed technology


Participation Criteria
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Eligibility Criteria
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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; 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D-printed group<br>The patient's breast blood supply was assessed preoperatively using 3D printing technology, and the flap was separated intraoperatively using a combination of cold knife and electrosurgical knife. | Procedure: 3D printed technology<br>* Preoperative application of 3D printing technology to evaluate the breast blood supply of patients and observe whether the incidence of ischemic complications in the flap and nipple areola complex is reduced compared to conventional non preoperative evaluation.<br>|
| Active Comparator: Normal group<br>Patients are not evaluated preoperatively using 3D printing technology and flap separation is performed using electrosurgical knife intraoperatively. | Procedure: 3D printed technology<br>* Preoperative application of 3D printing technology to evaluate the breast blood supply of patients and observe whether the incidence of ischemic complications in the flap and nipple areola complex is reduced compared to conventional non preoperative evaluation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ischemic complications of flap and nipple areola complex | The incidence of ischemic complications in the skin flap and nipple areola complex after NSM surgery | 1 week and 2 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of ischemic complications in the flap and nipple areola complex | Severity of ischemic complications in the skin flap and nipple areola complex after NSM surgery | 1 week and 2 week after surgery | 
| Duration of surgery | Record the duration of the procedure from the beginning of the incision to the end of the closure of the skin. | postoperative | 
| Blood loss | Comparison of hemoglobin values in the preoperative blood test with the results of 2-h postoperative test | Preoperative and 2 hours postoperatively | 
| Breast-Q Satisfaction | The outcome will be the score (continuous variable ranging from 0 to 100 for linear regression or ordinal categories, ranging from 1 to 4 for ordinallogistic regression, where 1 represents lowest satisfaction and 4 represents highest satisfaction), and the primary predictor of interest will be type of consultation provided. | Preoperative, 3 months and 1 year postoperatively |