Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction

January 19, 2026 updated by: The First Affiliated Hospital with Nanjing Medical University

Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction：an Open-label, Multicentre, Randomised, Controlled Trial

This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with prepectoral implant reconstruction. Furthermore, the study will compare the safety, aesthetic outcomes, and quality of life associated with the two surgical approaches. The study seeks to address the following primary research questions:

Does conventional surgery lead to superior recovery of breast skin sensation at 6 months postoperatively compared with endoscopic surgery?

What are the differences between the two surgical approaches in terms of complication rates, aesthetic outcomes, and patient-reported quality of life?

Researchers will compare conventional nipple-sparing mastectomy with endoscopic nipple-sparing mastectomy to determine which procedure better preserves postoperative breast sensation.

Participants will:

Be randomly assigned to undergo either conventional or endoscopic surgery.

Have breast skin sensation measured preoperatively and at multiple postoperative follow-up visits using a standardized assessment tool.

Complete validated questionnaires regarding breast satisfaction and quality of life preoperatively and during multiple follow-up visits.

Attend scheduled follow-up visits to monitor for complications and to evaluate the long-term appearance and health of the reconstructed breast.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female patients aged 18 to 70 years.
  2. Unilateral breast cancer confirmed by preoperative pathology.
  3. Scheduled to undergo nipple-sparing mastectomy (NSM) with immediate prepectoral implant-based breast reconstruction.
  4. Invasive carcinoma with a maximum tumor diameter ≤ 5 cm, or ductal carcinoma in situ (DCIS).
  5. Preoperative imaging assessment confirms a distance of ≥ 1 cm between the lesion and the nipple-areola complex (NAC).
  6. No clinical, radiological, or pathological evidence of tumor invasion into the NAC, skin, or pectoralis major muscle. The tumor must be confined within the glandular tissue.
  7. No evidence of distant metastasis (M0).
  8. Clinically node-negative (cN0) as assessed by preoperative examination.
  9. No history of neoadjuvant chemotherapy or radiotherapy prior to surgery.
  10. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  11. Willing and able to understand the study procedures, provide written informed consent, demonstrate good compliance, and agree to participate in follow-up evaluations.
  12. The principal surgeon must have experience in performing at least 30 cases of NSM combined with implant-based reconstruction.

Exclusion Criteria:

  1. Diagnosis of Paget's disease of the breast, recurrent breast cancer, or a history of prior thoracic radiation therapy.
  2. Evidence of tumor invasion into the skin (including inflammatory breast cancer), nipple-areola complex, or pectoralis major muscle.
  3. Pregnancy or lactation at the time of enrollment.
  4. Requirement for re-excision following a prior breast lump biopsy, or a history of any previous breast surgery (including but not limited to augmentation mammoplasty, breast reduction, lumpectomy, etc.).
  5. Breast size exceeding a D-cup.
  6. Body mass index (BMI) > 30 kg/m².
  7. Grade III ptosis (severe breast drooping where the nipple is positioned below the inframammary fold).
  8. Pre-existing nipple-areolar complex deformities (e.g., nipple inversion, areolar hypoplasia), active skin conditions of the breast (e.g., eczema, dermatitis, infection, ulceration), or significant scarring compromising the surgical site.
  9. Severe systemic comorbidities (e.g., immunosuppression, uncontrolled diabetes mellitus, severe cardiopulmonary dysfunction, coagulopathy or bleeding diathesis, contraindications to general anesthesia).
  10. Known hypersensitivity or allergy to silicone gel implants, or to anesthetic agents/antibiotics used perioperatively.
  11. Pre-existing neurological disorders (e.g., diabetic peripheral neuropathy, Parkinson's disease, polyneuritis, spinal cord injury) or chronic use of medications known to affect neurological/sensory function (e.g., antidepressants, antiepileptics).
  12. Current heavy smoking (>20 cigarettes per day).
  13. Current alcohol abuse or substance addiction.
  14. Concurrent or history of other active malignancies
  15. Anticipated poor compliance with follow-up protocols or inability to complete scheduled postoperative evaluations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Conventional nipple-sparing mastectomy group
Procedure: Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction
This procedure is a traditional surgical approach involving a skin incision made on the breast surface. Under direct visualization, the breast glandular tissue is excised while preserving the nipple-areola complex, followed by a reconstructive surgery with implant placement in the prepectoral plane.
Active Comparator: Endoscopic nipple-sparing mastectomy group
Procedure: Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction
This minimally invasive procedure is performed through small, concealed incisions in the axilla. Utilizing endoscopic instruments and an imaging system, the breast glandular tissue is resected under video monitoring, followed by reconstructive surgery with implant placement in the prepectoral plane.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Average breast sensory thresholds at 6 months post breast reconstruction as measured by Semmes-Weinstein Monofilaments
Time Frame: 6 months
Differences in the mean skin sensory thresholds (measured by Semmes-Weinstein monofilaments across nine breast regions) between the conventional and endoscopic surgery groups were observed at 6 months after breast reconstruction.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System within 1 year after surgery
Time Frame: within 1 year
Complications (e.g., hematoma, infection, flap necrosis) will be recorded and graded according to the Clavien-Dindo Classification System. The outcome is the count (and percentage) of participants experiencing at least one complication within the first postoperative year. These events are assessed at scheduled follow-up visits at 1, 3, 6, and 12 months.
within 1 year
Patient-reported quality of life as measured by Breast-Q reconstruction module
Time Frame: 6 months and 1 year
The Breast-Q reconstruction module assesses multiple domains, including psychosocial well-being, sexual well-being, physical well-being (of the chest and upper body), and satisfaction with breasts. All scores are transformed to a 0-100 scale.
6 months and 1 year
Physician-assessed breast aesthetic score using a 5-point Likert scale
Time Frame: 6 months and 1 year
Independent surgeons will rate five specific domains (volume, shape, symmetry, scar, NAC) on a 5-point Likert scale (1=very dissatisfied to 5=very satisfied) using blinded photographs. The mean score for each domain and the composite mean score will be compared between groups.
6 months and 1 year
Patient-reported quality of life as assessed by E0RTC QLQ-C30
Time Frame: 6 months and 1 year
Patient-reported quality of life measured by E0RTC QLQ-C30, consists of 30 items grouped into functional scales, symptom scales and single items, global health status scale. Responses for most items are recorded on a 4-point Likert scale (1="Not at all" to 4="Very much"). The two Global Health Status items use a 7-point linear analogue scale (1="Very poor" to 7="Excellent"). Raw scores are linearly transformed to a standardized score ranging from 0 to 100 for each scale. For the functional scales and the global health status scale: a higher score indicates a better level of functioning or quality of life. For the symptom scales / single Items: a higher score indicates a greater severity of symptoms or problems.
6 months and 1 year
Long-term breast skin sensation threshold as measured by Semmes-Weinstein Monofilaments
Time Frame: Annually up to 10 years
The mean pressure threshold, measured in grams using the Semmes-Weinstein monofilament test across nine standardized breast regions, will be compared between the conventional surgery group and the endoscopic surgery group after nipple-sparing mastectomy with prepectoral implant reconstruction for a long time.
Annually up to 10 years
Number of participants with postoperative complications as assessed by Clavien-Dindo Classification System after surgery in the long term.
Time Frame: Annually up to 10 years
Number of participants with postoperative complications assessed by Clavien-Dindo Classification System will be compared between two groups annually in the long term.
Annually up to 10 years
Long-term physician-assessed breast aesthetic score
Time Frame: Annually up to 10 years
Independent surgeons will rate five specific domains (volume, shape, symmetry, scar, NAC) on a 5-point Likert scale (1=very dissatisfied to 5=very satisfied) using blinded photographs. The mean score will be compared between groups at annual follow-ups.
Annually up to 10 years
Long-term patient-reported quality of life as measured by Breast-Q reconstruction module
Time Frame: Annually up to 10 years
The Breast-Q reconstruction module assesses multiple domains, including psychosocial well-being, sexual well-being, physical well-being (of the chest and upper body), and satisfaction with breasts. All scores are transformed to a 0-100 scale. The mean score will be compared between groups at annual follow-ups.
Annually up to 10 years
Long-term patient-reported quality of life as assessed by EORTC-QLQ-C30
Time Frame: Annually up to 10 years
Long-term patient-reported quality of life measured by E0RTC QLQ-C30, consists of 30 items grouped into functional scales, symptom scales and single items, global health status scale. Responses for most items are recorded on a 4-point Likert scale (1="Not at all" to 4="Very much"). The two Global Health Status items use a 7-point linear analogue scale (1="Very poor" to 7="Excellent"). Raw scores are linearly transformed to a standardized score ranging from 0 to 100 for each scale. For the functional scales and the global health status scale: a higher score indicates a better level of functioning or quality of life. For the symptom scales / single Items: a higher score indicates a greater severity of symptoms or problems.
Annually up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NJMU-BC11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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