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Breast NeoplasmsDIEP-MDSNCT07761390

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

An observational study of Breast Neoplasms and Breast Reconstruction, run by Zhuliling at 20 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years, women only
How many people
1,500 participants
Where
20 sitesChina
Study dates
1 Jan 2026to 31 Dec 2026
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites
  • Hunan Cancer Hospital and the Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University

    Changsha, Hunan, 410013

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523000

  • Dongguan Tungwah Hospital

    Dongguan, Guangdong, 523110

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

    Guangzhou, Guangdong, 510120

  • Guangzhou United Family Hospital

    Guangzhou, Guangdong, 510335

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

  • Guangzhou Concord Cancer Center

    Guangzhou, Guangdong, 510700

  • Guangzhou RoyalLee Cancer Hospital

    Guangzhou, Guangdong, 510700

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550001

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The Affiliated Huizhou Hospital, Guangzhou Medical University

    Huizhou, Guangdong, 516001

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514031

  • Shantou Central Hospital

    Shantou, Guangdong, 515031

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

    Shanwei, Guangdong, 516600

  • Yuebei People's Hospital

    Shaoguan, Guangdong, 512026

  • Shenzhen Maternity and Child Healthcare Hospital

    Shenzhen, Guangdong, 518000

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361001

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524001

Other trials in China

About this study

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

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.

Read the detailed description

Deep inferior epigastric artery perforator (DIEP) flap breast reconstruction is a cornerstone technique in autologous breast reconstruction after mastectomy. By preserving the rectus abdominis muscle while providing durable soft-tissue replacement, the DIEP flap provides reliable reconstructive volume and favorable aesthetic outcomes. Despite these advantages, the success of DIEP flap breast reconstruction depends critically on achieving and maintaining adequate flap perfusion.

Early postoperative flap-related vascular compromise-including venous congestion, arterial insufficiency, pedicle thrombosis, and pedicle kinking or torsion-may require unplanned surgical takeback and can result in flap failure. These events increase perioperative morbidity, expose patients to additional procedures, prolong hospitalization, and increase health care resource utilization. Preoperative identification of patients at increased risk of flap-related vascular compromise is therefore clinically important for surgical planning, patient counseling, and risk mitigation.

The vascular reliability of DIEP flap is closely related to DIEP perforator morphology, including perforator length, diameter, muscle thickness, and other anatomic features relevant to flap perfusion. Computed tomographic angiography (CTA) has become an integral component of preoperative planning for DIEP flap breast reconstruction and is widely used to map perforator anatomy and guide perforator selection. However, CTA-based assessment remains largely descriptive, with emphasis on anatomic mapping and selection of dominant perforators. Few studies have translated CTA-derived DIEP perforator morphology into a standardized quantitative framework for risk stratification of flap-related vascular compromise and flap failure.

We hypothesized that marked deviation of an individual's perforator anatomy from normative anatomic distributions may increase the technical complexity and unpredictability of flap harvest, intramuscular perforator dissection, and pedicle preparation. This deviation in DIEP morphology may predispose to intraoperative vascular traction, vessel injury, vasospasm, or suboptimal pedicle preparation, thereby potentially increasing the risk of early postoperative flap-related vascular compromise, subsequent unplanned surgical takeback, and flap failure.

In this multicenter retrospective observational study, we will develop a CTA-based quantitative risk score, termed the DIEP Morphological Deviation Score (DIEP-MDS). Using a reference CTA cohort of individuals without breast cancer or reconstructive surgery, we will first establish reference distributions for key anatomic features relevant to DIEP perforator morphology, including length, diameter, and muscle thickness. We will then convert CTA-derived anatomic features into a standardized deviation score that quantifies the extent to which a patient's perforator anatomy differs from these reference distributions. In the internal surgical cohort, the study will assess whether higher DIEP-MDS values are associated with increased risks of flap-related vascular compromise requiring unplanned surgical takeback, as well as flap failure. The score will subsequently be externally validated in an independent multicenter surgical cohort. 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.

Keywords
DIEP flap, Breast reconstruction, Computed tomography angiography, Vascular anatomy, Unplanned takeback
Medical subject headings
Breast Neoplasms, Postoperative Complications

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07761390
Study groupRoleWhat they receive
Reference CTA CohortAdult 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 CohortPatients 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 CohortPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)
  1. Unplanned Surgical Takeback for Flap-Related Vascular Compromise Within 48 Hours

    Return to the operating room within 48 hours after completion of the index DIEP flap surgery for exploration or intervention prompted by suspected or confirmed flap-related vascular compromise.

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

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

    Number and proportion of surgical cohort participants who experience either unplanned surgical takeback for suspected or confirmed flap-related vascular compromise within 48 hours after completion of the index DIEP flap surgery or total flap failure within 30 days after completion of the index DIEP flap surgery.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2026
  2. Study start1 Jan 2026
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07761390
Sponsor's protocol ID
SYSKY-DIEPCTA-2026
Acronym
DIEP-MDS
Status last verified
Aug 2026
First submitted
6 Aug 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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