Clinical trial · Observational
DIEP-MDS for Risk Stratification of Flap Vascular Compromise and Failure in Breast Reconstruction
A Multicenter Retrospective Study to Develop and Validate the CTA-Derived DIEP Morphological Deviation Score (DIEP-MDS) for Risk Stratification of Flap-Related Vascular Compromise and Flap Failure After DIEP Flap Breast Reconstruction
- 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)
This multicenter retrospective observational study will develop and validate a CTA-based quantitative risk score-the DIEP Morphological Deviation Score (DIEP-MDS)-to estimate the risk of flap-related vascular compromise and flap failure in patients undergoing DIEP flap breast reconstruction. The score will quantify the extent to which an individual's perforator anatomy deviates from normative anatomic distributions derived from a reference population of individuals without breast cancer or reconstructive surgery. Specifically, a cohort of randomly selected individuals with available CTA imaging will be used to establish population-level reference distributions for key anatomic features relevant to DIEP perforator morphology, including length, diameter, and muscle thickness. The study will determine whether greater deviation in DIEP morphology, as quantified by the DIEP-MDS, is associated with an increased risk of flap-related vascular compromise and flap failure. The score will be evaluated in an internal surgical cohort and externally validated in an independent multicenter surgical cohort. In addition, the study will pre-specify an analysis to assess whether a dual-pedicle strategy is associated with a lower risk of flap-related vascular compromise compared with a single-pedicle strategy across DIEP-MDS risk strata.
Conditions
Conditions (3)
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Breast Reconstruction | — | UNRESOLVED | — |
| Postoperative Complications | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Reference CTA Cohort
- description
- Adult women without breast cancer or reconstructive surgery who had available abdominal CTA imaging obtained for reasons unrelated to breast reconstruction. This cohort will be used to establish reference distributions for key anatomic features relevant to DIEP perforator morphology, including length, diameter, and muscle thickness.
- label
- Internal Surgical Cohort
- description
- Patients who underwent DIEP flap breast reconstruction at the coordinating center and had available preoperative abdominal CTA imaging. This cohort will be used to evaluate whether the CTA-derived DIEP Morphological Deviation Score (DIEP-MDS) is associated with flap-related vascular compromise and flap failure.
- label
- External Multicenter Surgical Cohort
- description
- Patients who underwent DIEP flap breast reconstruction at participating external centers and had available preoperative abdominal CTA imaging. This cohort will be used to externally validate the DIEP-MDS for estimating the risk of flap-related vascular compromise and flap failure.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria 1. Female participants aged 18 to 80 years. 2. Reference CTA cohort: adult women without breast cancer or reconstructive surgery who had available abdominal CTA imaging of sufficient quality, obtained for reasons unrelated to breast reconstruction. 3. Internal surgical cohort: patients who underwent DIEP flap breast reconstruction at the coordinating center, with available preoperative abdominal CTA imaging and traceable perioperative and outcome data. 4. External multicenter surgical cohort: patients who underwent DIEP flap breast reconstruction at participating external centers, with available preoperative abdominal CTA imaging and traceable perioperative and outcome data. 5. For the internal and external surgical cohorts, operative records must clearly document whether a single-pedicle strategy or dual-pedicle strategy was used. Exclusion Criteria 1. Prior abdominal flap harvest, abdominoplasty, major lower abdominal wall reconstruction, or extensive abdominal wall trauma or scarring expected to substantially alter DIEP perforator morphology. 2. Poor CTA image quality or insufficient image coverage for standardized assessment of key anatomic features relevant to DIEP perforator morphology. 3. Missing key clinical, imaging, operative, or outcome data required for the study analysis. 4. Non-DIEP abdominal flap procedures, combined flap procedures, or procedures in which DIEP flap anatomy, pedicle strategy, flap-related vascular compromise status, unplanned surgical takeback status, or flap failure status cannot be clearly determined. 5. For the reference CTA cohort, any history of breast reconstruction or abdominal wall procedures expected to substantially alter DIEP perforator morphology.
References
Publications (0)
Data not yet available