Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT07761390

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

Sponsor: Zhuliling

View on ClinicalTrials.gov

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