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.
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
- Conditions the study is for
- Breast Neoplasms, Breast Reconstruction, Postoperative Complications
- How many people
- 1,500 participants
- Where
- 20 sitesChina
- Study dates
- 1 Jan 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
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 group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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.
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.
- First posted12 Aug 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Zhuliling
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhuliling, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Liling Zhu, Study chair, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07761390
- Acronym / sponsor ID
- DIEP-MDS / SYSKY-DIEPCTA-2026
- Keywords
- DIEP flap, Breast reconstruction, Computed tomography angiography, Vascular anatomy, Unplanned takeback
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- ZhulilingUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With Total DIEP Flap Failure Within 30 Days
Time frame: Within 30 days after completion of the index DIEP flap surgery.
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.
2 secondary outcomes
Unplanned Surgical Takeback for Flap-Related Vascular Compromise Within 48 Hours
Time frame: Within 48 hours after completion of the index DIEP flap surgery.
Composite Early Flap-Related Vascular Compromise or Flap Failure Within 30 Days
Time frame: Within 30 days after completion of the index DIEP flap surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liling Zhu study chair
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Breast Reconstruction, run by Zhuliling at 20 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Total DIEP Flap Failure Within 30 Days (time frame: Within 30 days after completion of the index DIEP flap surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.