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DIEP-MDS for Risk Stratification of Flap Vascular Compromise and Failure in Breast Reconstruction
Sponsor: Zhuliling
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.
Official title: 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
Key Details
Gender
FEMALE
Age Range
18 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2026-01-01
Completion Date
2026-12-31
Last Updated
2026-08-12
Healthy Volunteers
No
Locations (20)
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
Dongguan People's Hospital
Dongguan, Guangdong, China
Dongguan Tungwah Hospital
Dongguan, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangzhou United Family Hospital
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
Guangzhou Concord Cancer Center
Guangzhou, Guangdong, China
Guangzhou RoyalLee Cancer Hospital
Guangzhou, Guangdong, China
The Affiliated Huizhou Hospital, Guangzhou Medical University
Huizhou, Guangdong, China
Meizhou People's Hospital
Meizhou, Guangdong, China
Shantou Central Hospital
Shantou, Guangdong, China
Shenshan Medical Center, Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Shanwei, Guangdong, China
Yuebei People's Hospital
Shaoguan, Guangdong, China
Shenzhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Hainan General Hospital
Haikou, Hainan, China
Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University
Changsha, Hunan, China
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, China
Yunnan Cancer Hospital
Kunming, Yunnan, China