Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy

NCT06071234 | Active Not Recruiting

• 1 other identifier: 3D-RECON
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical study is to explore whether preoperative application of 3D reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after surgery.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

3D-reconstruction group

EXPERIMENTAL

The participant's breast blood supply was assessed preoperatively using 3D reconstruction technology, and the flap was separated intraoperatively using a combination of electrocautery and sharp dissection.

Procedure: 3D reconstruction technology

Normal group

ACTIVE COMPARATOR

Participants are not evaluated preoperatively using 3D reconstruction technology and flap separation is performed using electrosurgical knife intraoperatively.

Procedure: 3D reconstruction technology

Interventions

3D reconstruction technology PROCEDURE

Preoperative application of 3D reconstruction technology to evaluate the breast blood supply of participants and observe whether the incidence of ischemic complications in the flap and nipple areola complex is reduced compared to surgery without preoperative evaluation.

3D-reconstruction group; Normal group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Participants who meet the indications for breast conserving surgery require total mastectomy and reconstruction;

You may not qualify if:

• Inability to tolerate surgery or subjective desire not to undergo nipple-sparing mastectomy;
• Participants 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;

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2023
• First Posted: October 6, 2023
• Study Start: October 8, 2023
• Primary Completion: April 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

CN (1)