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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Procedure: 3D reconstruction technology

• Registration Number: NCT06071234
• Lead Sponsor: Guangdong Provincial People's Hospital

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.

Study Timeline

• Study First Submitted: 2023-10-03
• Study First Submitted QC: 2023-10-03
• Study First Posted: 2023-10-06
• Study Start: 2023-10-08
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-21
• Last Update Posted: 2025-01-23
• Primary Completion: 2025-04-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3D-reconstruction group	3D reconstruction technology	The participant's breast blood supply was assessed preoperatively using 3D reconstruction technology, and the flap was separated intraoperatively using a combination of cold knife and electrosurgical knife.
Normal group	3D reconstruction technology	Participants are not evaluated preoperatively using 3D reconstruction technology and flap separation is performed using electrosurgical knife intraoperatively.

Primary Outcome Measures

Name	Time	Method
Ischemic complications of flap and nipple areola complex	1 week and 2 week after surgery	The incidence of ischemic complications in the skin flap and nipple areola complex after NSM surgery

Secondary Outcome Measures

Name	Time	Method
Severity of ischemic complications in the flap and nipple areola complex	1 week and 2 week after surgery	Severity of ischemic complications in the skin flap and nipple areola complex after NSM surgery
Duration of surgery	postoperative	Record the duration of the procedure from the beginning of the incision to the end of the closure of the skin.
Blood loss	Preoperative and 2 hours postoperatively	Comparison of hemoglobin values in the preoperative blood test with the results of 2-h postoperative test
Breast-Q Satisfaction	Preoperative, 3 months and 1 year postoperatively	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.

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangdong, China