Breast CancerNCT07410728
Comparison of Safety and Patients-Reported Outcomes Between Single-Port Endoscopic and Conventional Nipple-Sparing Mastectomy With Immediate Implant Reconstruction
An observational study of Breast Cancer and Breast Reconstruction, run by Xijing Hospital at 1 site in China.
Trial summary
Why is this study being done? Breast cancer is very common among women. Today, patients not only seek effective treatment but also care about their quality of life after surgery, including how they feel and how satisfied they are with the results. Doctors have developed different surgical methods. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Breast Reconstruction
- How many people
- 471 participants
- Where
- 1 siteChina
- Study dates
- 21 Apr 2021to 8 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective cohort study included adult female patients diagnosed with breast cancer who underwent nipple-sparing mastectomy (NSM) with immediate implant-based reconstruction at a single academic hospital between April 2021 and April 2024. Patients were categorized based on the surgical approach they received: endoscopic NSM (E-NSM) or conventional NSM (C-NSM).
Who may be able to join
- Female patients aged 18-65 years
- Preoperative pathological confirmation of breast malignancy via core needle biopsy (including phyllodes tumors, borderline lesions, or BRCA gene mutations undergoing prophylactic mastectomy)
- Imaging or intraoperative examination confirming no invasion of the tumor into the skin, subcutaneous tissue, or chest wall
- Contraindications to breast-conserving surgery or patient-initiated choice to undergo total mastectomy with immediate reconstruction
Who cannot join
- Patients undergoing delayed breast reconstruction
- Severe cardiopulmonary dysfunction or psychiatric disorders
- History of breast plastic surgery
- Long-term smokers
- Inflammatory breast cancer
- Diabetic patients with poorly controlled blood glucose
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of the Air Force Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Comparison of Safety and Patients-Reported Outcomes Between Single-Port Endoscopic and Conventional Nipple-Sparing Mastectomy With Immediate Implant Reconstruction: A Retrospective Cohort Study
Why is this study being done? Breast cancer is very common among women. Today, patients not only seek effective treatment but also care about their quality of life after surgery, including how they feel and how satisfied they are with the results. Doctors have developed different surgical methods. One newer method uses a tiny camera (called an endoscope) to perform the surgery through small openings, while the traditional method uses a larger incision. The newer method may lead to better cosmetic results and faster recovery, but its overall safety and impact on patients' daily life and well-being still need more evidence from research. This study aims to thoroughly compare these two surgical approaches to help doctors and patients make better-informed decisions.
What will happen in this study? This is a review study. We will look back at the medical records of about 471 women who underwent breast surgery with immediate reconstruction at our hospital between April 2021 and April 2024. Among them, about 342 patients had the newer endoscopic surgery, and 129 had the traditional surgery. We will compare information already in their records about surgery complications, cancer outcomes, and their answers to a quality-of-life questionnaire (called BREAST-Q).
Read more
Who can be in this study? The study includes adult women who had the specific types of breast surgery mentioned above at our hospital during that time.
What does this mean for patients? Because this study only reviews past medical records, no new actions or tests are required from any patients. We are only analyzing information that already exists. The results of this study may help future patients understand the potential benefits and risks of each surgical option, supporting more personalized and evidence-based healthcare choices.
Read the detailed description
- Study Objectives Primary Objective: To compare the surgical safety of endoscopic nipple-sparing mastectomy (E-NSM) versus conventional nipple-sparing mastectomy (C-NSM) with immediate implant-based reconstruction, as measured by postoperative complication rates. Secondary Objectives: To compare oncological safety between the two groups, assessed by disease-free survival (DFS). To compare patient-reported outcomes (PROs) between the two groups using the validated BREAST-Q version 2.0 questionnaire.
- Background \& Rationale Breast cancer remains a leading cause of cancer-related morbidity in women. Alongside oncological efficacy, patient satisfaction and health-related quality of life (HRQoL) have become critical endpoints in evaluating breast reconstruction outcomes. Nipple-sparing mastectomy (NSM) is favored for its superior cosmetic results. However, conventional NSM (C-NSM) requires a relatively large incision, which may impair blood supply to the nipple-areola complex (NAC), increasing the risk of necrosis. Minimally invasive techniques like endoscopic NSM (E-NSM) offer potential advantages, including smaller incisions and possibly better preservation of tissue perfusion. While E-NSM adoption is growing, robust comparative evidence on its safety profile and impact on patient-reported outcomes versus the established C-NSM is limited. Existing studies are often constrained by small sample sizes or the use of non-standardized PRO measures. This retrospective cohort study aims to provide a comprehensive comparative analysis to strengthen the evidence base for clinical decision-making regarding these two surgical approaches.
- Study Design This is a single-center, retrospective, observational cohort study conducted at The First Affiliated Hospital of the Air Force Medical University, a tertiary academic institution.
- Participant Selection Study Period: April 2021 to April 2024. Inclusion Criteria: Female patients aged 18-65 years who underwent immediate implant-based breast reconstruction following NSM. This includes patients with preoperative pathological confirmation of breast malignancy (including prophylactic mastectomy for high-risk lesions/BRCA mutations) and confirmed absence of skin/NAC involvement. Exclusion Criteria: Patients undergoing delayed reconstruction, those with severe cardiopulmonary/psychiatric comorbidities, prior breast plastic surgery, active long-term smoking, inflammatory breast cancer, or uncontrolled diabetes.
- Interventions \& Grouping Participants were categorized based on the surgical technique received: E-NSM Group (n=342): Surgery performed via a single axillary incision (5-8 cm) using endoscopic visualization and techniques to create and work within a gas-dissected cavity. C-NSM Group (n=129): Surgery performed via traditional incisions (e.g., inframammary fold) under direct vision. All procedures were performed by experienced senior breast surgical oncologists following standardized institutional protocols. All patients received adjuvant therapies (chemotherapy, endocrine therapy, radiotherapy) per established clinical guidelines (e.g., NCCN).
- Outcome Measures Primary Outcome (Safety): Incidence of postoperative complications, including flap ischemia/necrosis, nipple ischemia/necrosis, infection, seroma, implant removal, capsular contracture, and chronic pain. Secondary Outcomes: Oncological: Disease-free survival (DFS), local recurrence, and distant metastasis. Patient-Reported Outcomes: Scores from the BREAST-Q v2.0 questionnaire (domains: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being, Satisfaction with Care).
- Data Collection \& Follow-up Data were extracted retrospectively from electronic medical records. Follow-up was conducted every six months postoperatively via outpatient visits or telephone assessment. Data collected included demographics, clinicopathological features, surgical details, complications, oncological events, and BREAST-Q scores. Tumor markers and imaging (ultrasound, CT, bone scan) were used for recurrence surveillance.
- Statistical Analysis Data analysis will be performed using SPSS software (v27.0). Continuous variables will be compared using independent t-tests and reported as mean ± standard deviation. Categorical variables will be compared using Chi-square or Fisher's exact tests, as appropriate. Disease-free survival will be analyzed using Kaplan-Meier curves and the Log-rank test. A two-sided p-value < 0.05 will be considered statistically significant.
- Ethical \& Regulatory Considerations The study protocol was reviewed and approved by the Medical Ethics Committee of the First Affiliated Hospital of the Air Force Medical University (Approval No.: KY20232134-F-1). As a retrospective analysis of anonymized clinical data, the requirement for individual patient informed consent was waived. This study is reported in accordance with the STROCSS guidelines and has been registered prospectively on a public clinical trials registry.
- Conditions
- Breast Cancer, Breast Reconstruction
- Keywords
- Single-port endoscopic surgery, Breast reconstruction, BREAST-Q, Surgical Techniques
- Medical subject headings
- Breast Neoplasms
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 |
|---|---|---|
| E-NSM Group | Patients who underwent single-port endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction. | |
| C-NSM Group | Patients who underwent conventional nipple-sparing mastectomy with immediate implant-based breast reconstruction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-Reported Outcomes (PROs) as measured by BREAST-Q
Scores from the BREAST-Q version 2.0 questionnaire, including domains: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being (Chest, Back \& Shoulder), and Satisfaction with Care (Surgeon, Information). Higher scores indicate greater satisfaction or better quality of life.
Measured: 6 to 45 months postoperatively
Secondary outcomes (1)
Incidence of Postoperative Complications
The rate of surgical complications following mastectomy with reconstruction, including flap ischemia, flap necrosis, nipple ischemia, nipple necrosis, infection, seroma, implant removal, capsular contracture, and chronic pain. Complications will be graded according to the Clavien-Dindo classification.
Measured: up to 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start21 Apr 2021
- Primary completion21 Apr 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- 471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Juliang-1, Xijing Hospital
- Investigators
- Juliang Zhang, MD, PhD, Principal investigator, The First Affiliated Hospital of the Air Force Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07410728
- Sponsor's protocol ID
- KY20232134-F-1
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision regarding IPD sharing has not been finalized by the study team and the institution. Data sharing is contingent upon the development of a formal plan that ensures compliance with ethical regulations, protects participant privacy, and addresses institutional policies. Further details will be provided in the publication.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Safety and Patients-Reported Outcomes Between Single-Port Endoscopic and Conventional Nipple-Sparing Mastectomy With Immediate Implant Reconstruction: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07410728
- Acronym / sponsor ID
- KY20232134-F-1
- Conditions
- Breast Cancer, Breast Reconstruction
- Keywords
- Single-port endoscopic surgery, Breast reconstruction, BREAST-Q, Surgical Techniques
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 471 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 21 Apr 2024 (actual)
- Study completion
- 8 Jul 2024 (actual)
- First posted
- 13 Feb 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.
Why is this study being done? Breast cancer is very common among women. Today, patients not only seek effective treatment but also care about their quality of life after surgery, including how they feel and how satisfied they are with the results. Doctors have developed different surgical methods. One newer method uses a tiny camera (called an endoscope) to perform the surgery through small openings, while the traditional method uses a larger incision. The newer method may lead to better cosmetic results and faster recovery, but its overall safety and impact on patients' daily life and well-being still need more evidence from research. This study aims to thoroughly compare these two surgical approaches to help doctors and patients make better-informed decisions.
What will happen in this study? This is a review study. We will look back at the medical records of about 471 women who underwent breast surgery with immediate reconstruction at our hospital between April 2021 and April 2024. Among them, about 342 patients had the newer endoscopic surgery, and 129 had the traditional surgery. We will compare information already in their records about surgery complications, cancer outcomes, and their answers to a quality-of-life questionnaire (called BREAST-Q).
Who can be in this study? The study includes adult women who had the specific types of breast surgery mentioned above at our hospital during that time.
What does this mean for patients? Because this study only reviews past medical records, no new actions or tests are required from any patients. We are only analyzing information that already exists. The results of this study may help future patients understand the potential benefits and risks of each surgical option, supporting more personalized and evidence-based healthcare choices.
Detailed description
- Study Objectives Primary Objective: To compare the surgical safety of endoscopic nipple-sparing mastectomy (E-NSM) versus conventional nipple-sparing mastectomy (C-NSM) with immediate implant-based reconstruction, as measured by postoperative complication rates. Secondary Objectives: To compare oncological safety between the two groups, assessed by disease-free survival (DFS). To compare patient-reported outcomes (PROs) between the two groups using the validated BREAST-Q version 2.0 questionnaire.
- Background \& Rationale Breast cancer remains a leading cause of cancer-related morbidity in women. Alongside oncological efficacy, patient satisfaction and health-related quality of life (HRQoL) have become critical endpoints in evaluating breast reconstruction outcomes. Nipple-sparing mastectomy (NSM) is favored for its superior cosmetic results. However, conventional NSM (C-NSM) requires a relatively large incision, which may impair blood supply to the nipple-areola complex (NAC), increasing the risk of necrosis. Minimally invasive techniques like endoscopic NSM (E-NSM) offer potential advantages, including smaller incisions and possibly better preservation of tissue perfusion. While E-NSM adoption is growing, robust comparative evidence on its safety profile and impact on patient-reported outcomes versus the established C-NSM is limited. Existing studies are often constrained by small sample sizes or the use of non-standardized PRO measures. This retrospective cohort study aims to provide a comprehensive comparative analysis to strengthen the evidence base for clinical decision-making regarding these two surgical approaches.
- Study Design This is a single-center, retrospective, observational cohort study conducted at The First Affiliated Hospital of the Air Force Medical University, a tertiary academic institution.
- Participant Selection Study Period: April 2021 to April 2024. Inclusion Criteria: Female patients aged 18-65 years who underwent immediate implant-based breast reconstruction following NSM. This includes patients with preoperative pathological confirmation of breast malignancy (including prophylactic mastectomy for high-risk lesions/BRCA mutations) and confirmed absence of skin/NAC involvement. Exclusion Criteria: Patients undergoing delayed reconstruction, those with severe cardiopulmonary/psychiatric comorbidities, prior breast plastic surgery, active long-term smoking, inflammatory breast cancer, or uncontrolled diabetes.
- Interventions \& Grouping Participants were categorized based on the surgical technique received: E-NSM Group (n=342): Surgery performed via a single axillary incision (5-8 cm) using endoscopic visualization and techniques to create and work within a gas-dissected cavity. C-NSM Group (n=129): Surgery performed via traditional incisions (e.g., inframammary fold) under direct vision. All procedures were performed by experienced senior breast surgical oncologists following standardized institutional protocols. All patients received adjuvant therapies (chemotherapy, endocrine therapy, radiotherapy) per established clinical guidelines (e.g., NCCN).
- Outcome Measures Primary Outcome (Safety): Incidence of postoperative complications, including flap ischemia/necrosis, nipple ischemia/necrosis, infection, seroma, implant removal, capsular contracture, and chronic pain. Secondary Outcomes: Oncological: Disease-free survival (DFS), local recurrence, and distant metastasis. Patient-Reported Outcomes: Scores from the BREAST-Q v2.0 questionnaire (domains: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being, Satisfaction with Care).
- Data Collection \& Follow-up Data were extracted retrospectively from electronic medical records. Follow-up was conducted every six months postoperatively via outpatient visits or telephone assessment. Data collected included demographics, clinicopathological features, surgical details, complications, oncological events, and BREAST-Q scores. Tumor markers and imaging (ultrasound, CT, bone scan) were used for recurrence surveillance.
- Statistical Analysis Data analysis will be performed using SPSS software (v27.0). Continuous variables will be compared using independent t-tests and reported as mean ± standard deviation. Categorical variables will be compared using Chi-square or Fisher's exact tests, as appropriate. Disease-free survival will be analyzed using Kaplan-Meier curves and the Log-rank test. A two-sided p-value < 0.05 will be considered statistically significant.
- Ethical \& Regulatory Considerations The study protocol was reviewed and approved by the Medical Ethics Committee of the First Affiliated Hospital of the Air Force Medical University (Approval No.: KY20232134-F-1). As a retrospective analysis of anonymized clinical data, the requirement for individual patient informed consent was waived. This study is reported in accordance with the STROCSS guidelines and has been registered prospectively on a public clinical trials registry.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-NSM Group | – | –Patients who underwent single-port endoscopic nipple-sparing mastectomy with immediate implant-based breast reconstruction. |
| C-NSM Group | – | –Patients who underwent conventional nipple-sparing mastectomy with immediate implant-based breast reconstruction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective cohort study included adult female patients diagnosed with breast cancer who underwent nipple-sparing mastectomy (NSM) with immediate implant-based reconstruction at a single academic hospital between April 2021 and April 2024. Patients were categorized based on the surgical approach they received: endoscopic NSM (E-NSM) or conventional NSM (C-NSM).
Key inclusion criteria (4 listed)
- Female patients aged 18-65 years
- Preoperative pathological confirmation of breast malignancy via core needle biopsy (including phyllodes tumors, borderline lesions, or BRCA gene mutations undergoing prophylactic mastectomy)
- Imaging or intraoperative examination confirming no invasion of the tumor into the skin, subcutaneous tissue, or chest wall
- Contraindications to breast-conserving surgery or patient-initiated choice to undergo total mastectomy with immediate reconstruction
Key exclusion criteria (6 listed)
- Patients undergoing delayed breast reconstruction
- Severe cardiopulmonary dysfunction or psychiatric disorders
- History of breast plastic surgery
- Long-term smokers
- Inflammatory breast cancer
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
Patient-Reported Outcomes (PROs) as measured by BREAST-Q
Time frame: 6 to 45 months postoperatively
Scores from the BREAST-Q version 2.0 questionnaire, including domains: Satisfaction with Breasts, Psychosocial Well-being, Physical Well-being (Chest, Back \& Shoulder), and Satisfaction with Care (Surgeon, Information). Higher scores indicate greater satisfaction or better quality of life.
1 secondary outcome
Incidence of Postoperative Complications
Time frame: up to 3 months postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: Undecided. A decision regarding IPD sharing has not been finalized by the study team and the institution. Data sharing is contingent upon the development of a formal plan that ensures compliance with ethical regulations, protects participant privacy, and addresses institutional policies. Further details will be provided in the publication.
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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.
Juliang Zhang, MD, PhD principal investigator
The First Affiliated Hospital of the Air Force Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Reconstruction, run by Xijing Hospital 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Feb 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient-Reported Outcomes (PROs) as measured by BREAST-Q (time frame: 6 to 45 months postoperatively). 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 13 Feb 2026.