Breast CancerDEDTI-BRNCT07257003
A Nationwide Multicenter, Single-arm, Retrospective Study of Delayed Endoscopic DTI-BR After Simple Mastectomy
A study testing delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy in people with Breast Cancer, run by Du Zhenggui at 1 site in China.
Trial summary
This study is a nationwide multicenter, single-arm, retrospective study. The study aims to conduct a detailed analysis of operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety (e.g., surgical complication rates) in delayed endoscopic direct-to-implant breast… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 31 Dec 2026
- Phase
- Interventional
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Breast cancer patients who underwent delayed endoscopic direct-to-implant breast reconstruction after simple mastectomy at various centers from July 2024 to August 2025, all delayed endoscopic direct-to-implant breast reconstructions were performed ≥ 6 months after the initial mastectomy.
Who cannot join
- Poor skin elasticity;
- Re-evaluation (based on clinical, imaging, and pathological findings) indicates local or regional recurrence or uncontrolled distant metastasis;
- Patients who have previously undergone radical mastectomy;
- Patients who refused to provide postoperative follow-up information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Nationwide Multicenter, Single-arm, Retrospective Study on Delayed Endoscopic Direct-to-implant Breast Reconstruction Via Axillary Approach After Simple Mastectomy in Breast Cancer Patients
This study is a nationwide multicenter, single-arm, retrospective study. The study aims to conduct a detailed analysis of operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety (e.g., surgical complication rates) in delayed endoscopic direct-to-implant breast reconstruction via the axillary approach.
Read the detailed description
Breast cancer is the most common malignancy in women, with mastectomy remaining the predominant surgical approach in many regions-often leaving patients with psychological distress from breast loss. With the progress of treatment, patients' survival is prolonged and their quality of life is improved, so the demand for breast reconstruction is increasing. The two-stage implant-based breast reconstruction (TS-IBR) often needs two procedures, two anesthetics, and multiple hospital visits for the injection of water into the expander-costs that increase both financially and in time, ultimately affecting their work and daily routines. Ultimately, whether the procedure reopens the original scar or makes a new incision on the chest-and despite the skin being gradually expanded using an expander-there remains a high risk of dehiscence, implant exposure, infection, and even implant removal. Another method for breast reconstruction after total mastectomy is autologous breast reconstruction (ABR), which doesn't need a second operation. Still, it has serious scar problems and increases the risk of donor-site trauma and complications. Additionally, sensation and function at the donor site may be somewhat reduced, and both sites will likely have large scars, which can significantly impact the aesthetic results.
Therefore, the investigators need to find a simple, efficient, and safe method. The investigators developed the reverse-sequence endoscopic nipple-sparing mastectomy (R-E-NSM) with direct-to-implant breast reconstruction (DIBR), which changes the surgical sequence, makes the operation simple, and realizes immediate breast reconstruction. Inspired by endoscopic breast augmentation methods through the axillary incision, our team also developed a novel technique called delayed endoscopic direct-to-implant breast reconstruction (DEDTI-BR). Clinical practice shows that this technique is also suitable for patients after total mastectomy. This technique utilizes seroma for natural skin expansion, eliminates secondary operations, and preserves aesthetics without additional scars-significantly improving patients' quality of life. Despite its theoretical benefits, clinical evidence validating its efficacy and safety is currently lacking.
Therefore, the investigators plan to conduct a nationwide, multicenter, single-arm, retrospective study, analyzing operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety (e.g., surgical complication rates) in DEDTI-BR via the axillary approach. Our goal is to inform and guide clinical practice.
- Conditions
- Breast Cancer
- Being tested
- delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy
- Keywords
- Breast Cancer, Endoscopic surgery, Breast reconstruction, Minimal invasive surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomyProcedure or surgery
This technique allows for breast reconstruction in a single operation. Taking dual-plane breast reconstruction as an example, preoperative marking lines are drawn to indicate the contour and inframammary fold of the reconstructed breast. A 4-5 cm axillary incision is placed one finger-breadth below the axillary apex. After making the skin incision, the plane between the pectoralis major and minor muscles is identified and dissected, extending approximately 2 cm below the previous mastectomy horizontal scar. The inner and lower parts of the pectoralis major muscle were then separated. Proceed to the subcutaneous layer and continue to dissociate the flap until it reaches the pre-designed folds and the breast boundary. The use of the TiLOOP® Bra depends on the thickness of the patient's flap. Finally, the prosthesis is placed behind the pectoralis major muscle for breast reconstruction.
| Study group | Role | What they receive |
|---|---|---|
| DEDTI-BR group | Experimental | delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy Receives: Procedure: delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient's satisfaction with the breasts
Satisfaction with the breast of the BREAST-Q scale. The BREAST-Q is commonly used to assess health-related satisfaction and quality of life in patients who have undergone breast reconstruction after mastectomy. Responses for each subscale are scored from 0 to 100, with higher scores indicating better outcomes.
Measured: postoperative 6-month
Secondary outcomes (3)
The surgical safety
Surgical complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis
Measured: postoperative 6-month
The aesthetic outcomes
BREAST-Q scale (physical well-being: chest, psychosocial well-being, sexual well-being) and Harris scale. The BREAST-Q is commonly used to assess health-related satisfaction and quality of life in patients who have undergone breast reconstruction after mastectomy. Responses for each subscale are scored from 0 to 100, with higher scores indicating better outcomes. The Harris score is used to evaluate the postoperative cosmetic outcome, which is classified as excellent, good, general, and poor.
Measured: postoperative 6-month
The implant-assisted complications
Implant-assisted complication rates, including rippling, prosthesis outline appearance, capsular contraction, animation deformity, pectoralis major pain, pectoralis major muscle spasm
Measured: postoperative 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025 (estimated)
- 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.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Du Zhenggui
- Sponsor type
- University, hospital or other
- Collaborators
- Fujian Cancer Hospital, Suzhou Municipal Hospital, The Second People's Hospital of Yibin, Mianyang Central Hospital, West China Hospital, Fourth People's Hospital of Sichuan Province
- Responsible party
- Sponsor-investigator, Du Zhenggui, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257003
- Sponsor's protocol ID
- 2025(1896)
- Acronym
- DEDTI-BR
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.
Publications
Xiu B, Zhang Q, Meng X, Hao S, Yang B, Li J, Shao ZM, Wu J; Chinese Anti-Cancer Association; Committee of Breast Cancer Society. Current practices and challenges of endoscopic-assisted breast surgery in China: A nationwide cross-sectional survey. Eur J Surg Oncol. 2025 May;51(5):109620. doi: 10.1016/j.ejso.2025.109620. Epub 2025 Jan 19.
PubMed 39842261Bennett KG, Qi J, Kim HM, Hamill JB, Pusic AL, Wilkins EG. Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct 1;153(10):901-908. doi: 10.1001/jamasurg.2018.1687.
PubMed 29926077Ren Y, Yu Y, Xu K, Li Z, Wang X. Meta-Analysis of Immediate Implant-Based Breast Reconstruction Versus Autologous Breast Reconstruction in the Setting of PMRT. Aesthetic Plast Surg. 2024 May;48(10):1940-1948. doi: 10.1007/s00266-023-03430-y. Epub 2023 Jun 28.
PubMed 37380747Movassaghi K, Gilson A, Stewart CN, Cusic J, Movassaghi A. Prepectoral Two-Stage Implant-Based Breast Reconstruction with Poly-4-Hydroxybutyrate for Pocket Control without the Use of Acellular Dermal Matrix: A 4-Year Review. Plast Reconstr Surg. 2024 Jul 1;154(1):15-24. doi: 10.1097/PRS.0000000000010914. Epub 2023 Jul 6.
PubMed 37410610Deliere A, Attai D, Victorson D, Kuchta K, Pesce C, Kopkash K, Sisco M, Seth A, Yao K. Patients Undergoing Bilateral Mastectomy and Breast-Conserving Surgery Have the Lowest Levels of Regret: The WhySurg Study. Ann Surg Oncol. 2021 Oct;28(10):5686-5697. doi: 10.1245/s10434-021-10452-w. Epub 2021 Aug 25.
PubMed 34432189Erden Y, Celik HC, Karakurt N. Women's body image after mastectomy: a photovoice study. Support Care Cancer. 2025 May 27;33(6):501. doi: 10.1007/s00520-025-09541-3.
PubMed 40423833
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nationwide Multicenter, Single-arm, Retrospective Study on Delayed Endoscopic Direct-to-implant Breast Reconstruction Via Axillary Approach After Simple Mastectomy in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07257003
- Acronym / sponsor ID
- DEDTI-BR / 2025(1896)
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Endoscopic surgery, Breast reconstruction, Minimal invasive surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Du ZhengguiUniversity, hospital or other
- Collaborators
- Fujian Cancer Hospital, Suzhou Municipal Hospital, The Second People's Hospital of Yibin, Mianyang Central Hospital, West China Hospital, Fourth People's Hospital of Sichuan Province
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Dec 2025 (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 study is a nationwide multicenter, single-arm, retrospective study. The study aims to conduct a detailed analysis of operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety (e.g., surgical complication rates) in delayed endoscopic direct-to-implant breast reconstruction via the axillary approach.
Detailed description
Breast cancer is the most common malignancy in women, with mastectomy remaining the predominant surgical approach in many regions-often leaving patients with psychological distress from breast loss. With the progress of treatment, patients' survival is prolonged and their quality of life is improved, so the demand for breast reconstruction is increasing. The two-stage implant-based breast reconstruction (TS-IBR) often needs two procedures, two anesthetics, and multiple hospital visits for the injection of water into the expander-costs that increase both financially and in time, ultimately affecting their work and daily routines. Ultimately, whether the procedure reopens the original scar or makes a new incision on the chest-and despite the skin being gradually expanded using an expander-there remains a high risk of dehiscence, implant exposure, infection, and even implant removal. Another method for breast reconstruction after total mastectomy is autologous breast reconstruction (ABR), which doesn't need a second operation. Still, it has serious scar problems and increases the risk of donor-site trauma and complications. Additionally, sensation and function at the donor site may be somewhat reduced, and both sites will likely have large scars, which can significantly impact the aesthetic results.
Therefore, the investigators need to find a simple, efficient, and safe method. The investigators developed the reverse-sequence endoscopic nipple-sparing mastectomy (R-E-NSM) with direct-to-implant breast reconstruction (DIBR), which changes the surgical sequence, makes the operation simple, and realizes immediate breast reconstruction. Inspired by endoscopic breast augmentation methods through the axillary incision, our team also developed a novel technique called delayed endoscopic direct-to-implant breast reconstruction (DEDTI-BR). Clinical practice shows that this technique is also suitable for patients after total mastectomy. This technique utilizes seroma for natural skin expansion, eliminates secondary operations, and preserves aesthetics without additional scars-significantly improving patients' quality of life. Despite its theoretical benefits, clinical evidence validating its efficacy and safety is currently lacking.
Therefore, the investigators plan to conduct a nationwide, multicenter, single-arm, retrospective study, analyzing operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety (e.g., surgical complication rates) in DEDTI-BR via the axillary approach. Our goal is to inform and guide clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DEDTI-BR group | Experimental | Procedure: delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomydelayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Breast cancer patients who underwent delayed endoscopic direct-to-implant breast reconstruction after simple mastectomy at various centers from July 2024 to August 2025, all delayed endoscopic direct-to-implant breast reconstructions were performed ≥ 6 months after the initial mastectomy.
Key exclusion criteria (4 listed)
- Poor skin elasticity;
- Re-evaluation (based on clinical, imaging, and pathological findings) indicates local or regional recurrence or uncontrolled distant metastasis;
- Patients who have previously undergone radical mastectomy;
- Patients who refused to provide postoperative follow-up information.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomyThis technique allows for breast reconstruction in a single operation. Taking dual-plane breast reconstruction as an example, preoperative marking lines are drawn to indicate the contour and inframammary fold of the reconstructed breast. A 4-5 cm axillary incision is placed one finger-breadth below the axillary apex. After making the skin incision, the plane between the pectoralis major and minor muscles is identified and dissected, extending approximately 2 cm below the previous mastectomy horizontal scar. The inner and lower parts of the pectoralis major muscle were then separated. Proceed to the subcutaneous layer and continue to dissociate the flap until it reaches the pre-designed folds and the breast boundary. The use of the TiLOOP® Bra depends on the thickness of the patient's flap. Finally, the prosthesis is placed behind the pectoralis major muscle for breast reconstruction. | Procedure or surgery | DEDTI-BR group |
Primary outcome
The patient's satisfaction with the breasts
Time frame: postoperative 6-month
Satisfaction with the breast of the BREAST-Q scale. The BREAST-Q is commonly used to assess health-related satisfaction and quality of life in patients who have undergone breast reconstruction after mastectomy. Responses for each subscale are scored from 0 to 100, with higher scores indicating better outcomes.
3 secondary outcomes
The surgical safety
Time frame: postoperative 6-month
The aesthetic outcomes
Time frame: postoperative 6-month
The implant-assisted complications
Time frame: postoperative 6-month
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 2 Dec 2025.
- Background: PubMed 39842261Xiu B, Zhang Q, Meng X, Hao S, Yang B, Li J, Shao ZM, Wu J; Chinese Anti-Cancer Association; Committee of Breast Cancer Society. Current practices and challenges of endoscopic-assisted breast surgery in China: A nationwide cross-sectional survey. Eur J Surg Oncol. 2025 May;51(5):109620. doi: 10.1016/j.ejso.2025.109620. Epub 2025 Jan 19.
- Background: PubMed 29926077Bennett KG, Qi J, Kim HM, Hamill JB, Pusic AL, Wilkins EG. Comparison of 2-Year Complication Rates Among Common Techniques for Postmastectomy Breast Reconstruction. JAMA Surg. 2018 Oct 1;153(10):901-908. doi: 10.1001/jamasurg.2018.1687.
- Background: PubMed 37380747Ren Y, Yu Y, Xu K, Li Z, Wang X. Meta-Analysis of Immediate Implant-Based Breast Reconstruction Versus Autologous Breast Reconstruction in the Setting of PMRT. Aesthetic Plast Surg. 2024 May;48(10):1940-1948. doi: 10.1007/s00266-023-03430-y. Epub 2023 Jun 28.
- Background: PubMed 37410610Movassaghi K, Gilson A, Stewart CN, Cusic J, Movassaghi A. Prepectoral Two-Stage Implant-Based Breast Reconstruction with Poly-4-Hydroxybutyrate for Pocket Control without the Use of Acellular Dermal Matrix: A 4-Year Review. Plast Reconstr Surg. 2024 Jul 1;154(1):15-24. doi: 10.1097/PRS.0000000000010914. Epub 2023 Jul 6.
- Background: PubMed 34432189Deliere A, Attai D, Victorson D, Kuchta K, Pesce C, Kopkash K, Sisco M, Seth A, Yao K. Patients Undergoing Bilateral Mastectomy and Breast-Conserving Surgery Have the Lowest Levels of Regret: The WhySurg Study. Ann Surg Oncol. 2021 Oct;28(10):5686-5697. doi: 10.1245/s10434-021-10452-w. Epub 2021 Aug 25.
- Background: PubMed 40423833Erden Y, Celik HC, Karakurt N. Women's body image after mastectomy: a photovoice study. Support Care Cancer. 2025 May 27;33(6):501. doi: 10.1007/s00520-025-09541-3.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy in people with Breast Cancer, run by Du Zhenggui at 1 site 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 1 inclusion and 4 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: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Zhenggui Du (+86 13880768222, docduzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The patient's satisfaction with the breasts (time frame: postoperative 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07257003, which also lists 6 linked publications.
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 2 Dec 2025.