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

NCT07761390 | Active Not Recruiting DMC

• 1 other identifier: SYSKY-DIEPCTA-2026
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Breast Neoplasms; Breast Reconstruction; Postoperative Complications

Keywords

DIEP flap; Breast reconstruction; Computed tomography angiography; Vascular anatomy; Unplanned takeback

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Total DIEP Flap Failure Within 30 Days

  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.

  Within 30 days after completion of the index DIEP flap surgery.

Secondary Outcomes (2)

• Unplanned Surgical Takeback for Flap-Related Vascular Compromise Within 48 Hours

  Within 48 hours after completion of the index DIEP flap surgery.

• Composite Early Flap-Related Vascular Compromise or Flap Failure Within 30 Days

  Within 30 days after completion of the index DIEP flap surgery.

Study Arms (3)

Reference CTA Cohort

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.

Internal Surgical Cohort

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.

External Multicenter Surgical Cohort

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult women will be included in three cohorts. The reference CTA cohort will include women without breast cancer or reconstructive surgery who underwent abdominal CTA for reasons unrelated to breast reconstruction and will establish reference distributions for key anatomic features relevant to DIEP perforator morphology. The internal surgical cohort will include patients who underwent DIEP flap breast reconstruction at the coordinating center and will evaluate the association between the DIEP Morphological Deviation Score (DIEP-MDS) and flap-related vascular compromise and flap failure. The external multicenter surgical cohort will include patients from external centers for external validation of the DIEP-MDS. Clinical outcomes will be assessed only in the surgical cohorts.

You may qualify if:

• Female participants aged 18 to 80 years.
• 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.
• 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.
• 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.
• For the internal and external surgical cohorts, operative records must clearly document whether a single-pedicle strategy or dual-pedicle strategy was used.

You may not qualify if:

• Prior abdominal flap harvest, abdominoplasty, major lower abdominal wall reconstruction, or extensive abdominal wall trauma or scarring expected to substantially alter DIEP perforator morphology.
• Poor CTA image quality or insufficient image coverage for standardized assessment of key anatomic features relevant to DIEP perforator morphology.
• Missing key clinical, imaging, operative, or outcome data required for the study analysis.
• 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.
• For the reference CTA cohort, any history of breast reconstruction or abdominal wall procedures expected to substantially alter DIEP perforator morphology.

Sponsors & Collaborators

• Zhuliling: lead

Study Sites (20)

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, 361001, China

Location

Dongguan People's Hospital

Dongguan, Guangdong, 523000, China

Location

Dongguan Tungwah Hospital

Dongguan, Guangdong, 523110, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

Location

Guangzhou United Family Hospital

Guangzhou, Guangdong, 510335, China

Location

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Guangzhou Concord Cancer Center

Guangzhou, Guangdong, 510700, China

Location

Guangzhou RoyalLee Cancer Hospital

Guangzhou, Guangdong, 510700, China

Location

The Affiliated Huizhou Hospital, Guangzhou Medical University

Huizhou, Guangdong, 516001, China

Location

Meizhou People's Hospital

Meizhou, Guangdong, 514031, China

Location

Shantou Central Hospital

Shantou, Guangdong, 515031, China

Location

Shenshan Medical Center, Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Shanwei, Guangdong, 516600, China

Location

Yuebei People's Hospital

Shaoguan, Guangdong, 512026, China

Location

Shenzhen Maternity and Child Healthcare Hospital

Shenzhen, Guangdong, 518000, China

Location

Affiliated Hospital of Guangdong Medical University

Zhanjiang, Guangdong, 524001, China

Location

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, 550001, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

Changsha, Hunan, 410013, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Yunnan Cancer Hospital

Kunming, Yunnan, 650118, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Liling Zhu

  Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Chief Surgeon

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)