Actively Recruiting
Comparison of Prepectoral and Subpectoral Breast Reconstruction Following Single-port Insufflation Endoscopic Nipple-sparing Mastectomy
Led by Beijing Friendship Hospital · Updated on 2023-04-27
88
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
B
Beijing Friendship Hospital
Lead Sponsor
B
Beijing Health Promotion Association
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are comparing two breast reconstruction methods following single-port insufflation endoscopic nipple-sparing mastectomy in women with early-stage invasive breast cancer. This observational study evaluates pre-pectoral breast reconstruction against subpectoral breast reconstruction, focusing primarily on patient breast satisfaction. The study is conducted by Beijing Friendship Hospital and includes patients treated retrospectively from 2014 to 2022 and prospectively from 2022 to 2025. Participants receive either prepectoral or subpectoral breast reconstruction after the nipple-sparing mastectomy. Both groups undergo the same mastectomy technique, with differences in the placement of the breast implant. The study aims to enroll 44 patients in each group, accounting for a possible loss to follow-up, to compare outcomes between these two reconstruction approaches. During the study, patients' breast satisfaction will be measured using the BREAST-Q score 12 months after surgery. Secondary assessments include physical well-being of the chest, animation deformity, adverse events within 30 days post-surgery, and breast cancer recurrence or metastasis at 12 months. Data will be collected through medical record reviews and follow-up evaluations to monitor safety and outcomes over the study period.
CONDITIONS
Brief Title
Comparison Between Prepectoral and Subpectoral Breast Reconstruction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients with early-stage invasive breast cancer (stage I or II) confirmed by biopsy
- Breast-conserving surgery not possible or patient requests total mastectomy
- Willingness to undergo breast reconstruction
- Age between 18 and 70 years
- Cancer lesion diameter of 3 cm or less
- Tumor confirmed not to invade skin, subcutaneous tissue, or chest wall by exam and MRI
- Distance between lesion and nipple at least 2 cm with no invasion of nipple-areola complex
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2
You will not qualify if you...
- Serious medical conditions such as unstable angina, recent heart attack, or stroke within 6 months
- History of other malignant tumors within past 5 years
- Current immunosuppressive therapy for organ transplant
- Continuous systemic steroid hormone therapy
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and up to 30 days after surgery
Participants undergo single-port insufflation endoscopic nipple-sparing mastectomy followed by either prepectoral or subpectoral breast reconstruction.
Approximately 1 surgery day and multiple visits within 30 days post-surgery
Duration - 12 months after surgery
Participants are followed to assess breast satisfaction, physical well-being of the chest, animation deformity, and monitor for local recurrence and distant metastasis of breast cancer.
Scheduled follow-up visits during 12 months after surgery
Trial Site Locations
Total: 1 location
1
Beijing Friendship Hospital, Capital medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
G
guoxuan gao, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here