Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastecto… (NCT07372339) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction
170 participantsStarted 2026-03
Plain-language summary
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.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Female patients aged 18 to 70 years.
. Unilateral breast cancer confirmed by preoperative pathology.
. Scheduled to undergo nipple-sparing mastectomy (NSM) with immediate prepectoral implant-based breast reconstruction.
. Invasive carcinoma with a maximum tumor diameter ≤ 5 cm, or ductal carcinoma in situ (DCIS).
. Preoperative imaging assessment confirms a distance of ≥ 1 cm between the lesion and the nipple-areola complex (NAC).
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average breast sensory thresholds at 6 months post breast reconstruction as measured by Semmes-Weinstein Monofilaments
Timeframe: 6 months
Trial details
NCT IDNCT07372339
SponsorThe First Affiliated Hospital with Nanjing Medical University
. Clinically node-negative (cN0) as assessed by preoperative examination.
Exclusion criteria
. Diagnosis of Paget's disease of the breast, recurrent breast cancer, or a history of prior thoracic radiation therapy.
. Evidence of tumor invasion into the skin (including inflammatory breast cancer), nipple-areola complex, or pectoralis major muscle.
. Pregnancy or lactation at the time of enrollment.
. 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.).
. Breast size exceeding a D-cup.
. Body mass index (BMI) \> 30 kg/m².
. Grade III ptosis (severe breast drooping where the nipple is positioned below the inframammary fold).
. 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.