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Clinical Trials in China / NCT07761390
Active, not recruiting Observational

DIEP-MDS for Risk Stratification of Flap Vascular Compromise and Failure in Breast Reconstruction

NCT07761390 · tracked via the Priya Life Science China tracker
Sponsor
Zhuliling
Phase
Observational
Started
2026-01-01
Last updated
2026-08-12

Condition(s) studied

Breast NeoplasmsBreast ReconstructionPostoperative Complications

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Number of Participants With Total DIEP Flap Failure Within 30 Days — Within 30 days after completion of the index DIEP flap surgery.
    Total DIEP flap failure will be assessed as a binary outcome (yes/no) through review of postoperative clinical assessments and reoperation records. Total flap failure is defined as complete and irreversible loss of viability of the reconstructed DIEP flap resulting in complete flap removal. The outcome will be reported as the number and percentage of participants who experience total flap failure.

Trial sites (20)

FacilityCityRegionStatus
The First Affiliated Hospital of Xiamen University Xiamen Fujian
Dongguan People's Hospital Dongguan Guangdong
Dongguan Tungwah Hospital Dongguan Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Guangzhou Guangdong
Guangzhou United Family Hospital Guangzhou Guangdong
Nanfang Hospital, Southern Medical University Guangzhou Guangdong
Guangzhou Concord Cancer Center Guangzhou Guangdong
Guangzhou RoyalLee Cancer Hospital Guangzhou Guangdong
The Affiliated Huizhou Hospital, Guangzhou Medical University Huizhou Guangdong
Meizhou People's Hospital Meizhou Guangdong
Shantou Central Hospital Shantou Guangdong
Shenshan Medical Center, Sun Yat-sen Memorial Hospital of Sun Yat-sen University Shanwei Guangdong
Yuebei People's Hospital Shaoguan Guangdong
Shenzhen Maternity and Child Healthcare Hospital Shenzhen Guangdong
Affiliated Hospital of Guangdong Medical University Zhanjiang Guangdong
Affiliated Hospital of Guizhou Medical University Guiyang Guizhou
Hainan General Hospital Haikou Hainan
Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University Changsha Hunan
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality
Yunnan Cancer Hospital Kunming Yunnan

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A Study of Treatment-Related Toxicities and Quality of Life After Local Therapy in Chinese Breast Cancer Patients Recruiting
Health Belief Model-Based Survey on Breast Self-Examination Awareness and Practice Among Community-Dwelling Middle-Aged and Older Women Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07761390 on ClinicalTrials.gov ↗ ← All trials in China