Endoscopic and robotic nipple-sparing mastectomy with immediate breast reconstruction
Prospective Cohort Study of Minimally Invasive Surgery Versus Traditional Open Surgery for Nipple Areola Preserving Mastectomy Combined with Immediate Prosthesis Reconstruction
This study is testing a new type of breast surgery that uses advanced techniques to remove cancer while keeping the nipple and immediately placing an implant to see if it helps patients feel better about their appearance and recover well.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 484 (estimated) |
| Sex | Female |
| Sponsor | Peking University People's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06748677 on ClinicalTrials.gov |
What this trial studies
This study focuses on evaluating the safety and aesthetic outcomes of endoscopic and robotic nipple-sparing mastectomy (NSM) combined with immediate prosthesis breast reconstruction for patients with early-stage breast cancer. It aims to gather large-scale prospective data to support the effectiveness of this surgical approach, which is designed to minimize physical and psychological trauma associated with breast cancer surgery. Patients will be monitored postoperatively and asked to complete Patient Reported Outcome Measures (PROMs) questionnaires to assess their satisfaction and recovery.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with early-stage breast cancer (stage 0-IIIB) who are eligible for nipple-sparing mastectomy and immediate reconstruction.
Not a fit: Patients with metastatic breast cancer, bilateral breast cancer, or those who have previously undergone breast-conserving surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and aesthetic outcomes for patients undergoing mastectomy.
How similar studies have performed: Previous literature suggests that similar approaches have shown promising results, but large-scale prospective data is still lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Underwent surgical treatment at Peking University People's Hospital, with hospitalization records; 2. Preoperative core needle biopsy confirmed breast cancer; 3. The clinical stage of the tumor is stage 0-IIIB; 4）cT≤5cm， cN0/cN1，M0， And there is no tumor invasion of the nipple areola complex, skin, and chest wall; 5\) Intraoperative plan to use non biological patches (such as TiLoop) to partially or completely wrap the prosthesis 6) Signed agreement to participate in this study; 7) Can cooperate to complete the Patient Reported Outcome Measures (PROMs) questionnaire. Exclusion Criteria: 1. Lack of clinical pathological data (such as imaging data, pathological data); 2. Pregnancy or lactation period; 3. Patients with metastatic breast cancer or bilateral breast cancer; 4. Have undergone breast conserving surgery/chest radiation therapy before; 5. Patients with nipple areola invasion and subsequent removal of nipple areola complex; 6. Failed to undergo curative surgery;
Where this trial is running
Beijing, Beijing Municipality
- Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: yuan peng, doctor
- Email: 13671287670@163.com
- Phone: 86+13671287670
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.