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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: 3D printed technology

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.

• Study Type: Interventional
• Enrollment (Estimated): 126
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 3D-printed group; 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; 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.
Active Comparator: Normal group; Patients are not evaluated preoperatively using 3D printing technology and flap separation is performed using electrosurgical knife intraoperatively.	Procedure: 3D printed technology; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guangdong Provincial People's Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 8, 2023
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: October 3, 2023
• First Submitted That Met QC Criteria: October 3, 2023
• First Posted (Actual): October 6, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 3D-PRT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No