Clinical trial · Interventional
Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy
An Exploration of 3D Reconstruction Tool for Preoperative Evaluation in Reducing Ischemic Complications of Flap and Nipple-Areolar Complex (NAC) After Nipple-sparing Mastectomy
NCT06071234CI-TRIAL-00085031active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 3D reconstruction technology | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 3D-reconstruction group
- description
- 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.
- interventionNames
- Procedure: 3D reconstruction technology
- type
- ACTIVE_COMPARATOR
- label
- Normal group
- description
- Participants are not evaluated preoperatively using 3D reconstruction technology and flap separation is performed using electrosurgical knife intraoperatively.
- interventionNames
- Procedure: 3D reconstruction technology
Primary outcomes (1)
- measure
- Ischemic complications of flap and nipple areola complex
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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; * Participants 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; * 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;
References
Publications (0)
Data not yet available
No reference posted for this study.