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CT scans may predict breast reconstruction flap failure

NCT ID NCT07761390

Knowledge-focused Sponsor: Zhuliling Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study looks at whether a new scoring system, called the DIEP-MDS, can help predict the risk of blood flow problems and flap failure after DIEP flap breast reconstruction. The score is based on CT scans of the abdomen, measuring features of the blood vessels used in the surgery. Researchers will analyze data from 1,500 women, including those who had the surgery and a comparison group, to see if greater deviation from normal anatomy is linked to higher risk. The goal is to develop a tool that could help surgeons plan safer procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give surgeons a tool to better predict which patients are at higher risk of flap failure, potentially guiding surgical decisions to improve outcomes.
What could go wrong
This is an observational study, so it cannot prove cause and effect. The scoring system may not be accurate across all patients or hospitals, and further validation is needed before it can be used in practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 80 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast neoplasm Postoperative Complications

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms Breast reconstruction Postoperative complications

Contacts and locations

Locations

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524001, China

  • Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou, 550001, China

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523000, China

  • Dongguan Tungwah Hospital

    Dongguan, Guangdong, 523110, China

  • Guangzhou Concord Cancer Center

    Guangzhou, Guangdong, 510700, China

  • Guangzhou RoyalLee Cancer Hospital

    Guangzhou, Guangdong, 510700, China

  • Guangzhou United Family Hospital

    Guangzhou, Guangdong, 510335, China

  • Hainan General Hospital

    Haikou, Hainan, 570311, China

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

    Changsha, Hunan, 410013, China

  • Meizhou People's Hospital

    Meizhou, Guangdong, 514031, China

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515, China

  • Shantou Central Hospital

    Shantou, Guangdong, 515031, China

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

    Shanwei, Guangdong, 516600, China

  • Shenzhen Maternity and Child Healthcare Hospital

    Shenzhen, Guangdong, 518000, China

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

    Guangzhou, Guangdong, 510120, China

  • The Affiliated Huizhou Hospital, Guangzhou Medical University

    Huizhou, Guangdong, 516001, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361001, China

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060, China

  • Yuebei People's Hospital

    Shaoguan, Guangdong, 512026, China

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650118, China

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