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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06071234
• Other study ID #: 3D-PRT
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 8, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: October 2023
• Source: Guangdong Provincial People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: December 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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;

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Blood loss	Comparison of hemoglobin values in the preoperative blood test with the results of 2-h postoperative test	Preoperative and 2 hours postoperatively
Secondary	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