Last reviewed · How we verify
NCT06748677: EnRoNSM
Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction
trial in Nipple-sparing Mastectomy in 484 participants. Currently enrolling.
31 December 2028
Quick facts
| Lead sponsor | Peking University People's Hospital |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 484 |
| Start date | 3 January 2025 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2031 |
| Sites | 1 location across China |
Conditions studied
- Nipple-sparing Mastectomy — all drugs for Nipple-sparing Mastectomy →
- Immediate Prosthesis Reconstruction — all drugs for Immediate Prosthesis Reconstruction →
- Endoscopic Surgery — all drugs for Endoscopic Surgery →
- Robotic Surgery — all drugs for Robotic Surgery →
Sponsor
Peking University People's Hospital
Who can join
Eligibility, female only, with Nipple-sparing Mastectomy or Immediate Prosthesis Reconstruction. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Breast cancer is the most common malignant tumor in women. Surgical treatment is the most important treatment for early breast cancer. Breast cancer resection is considered to be a destructive operation. Patients need to accept the double blow of physical and psychological loss of breast shape. Although with the change of the concept of early diagnosis and treatment of breast cancer, the breast conserving rate of breast cancer is gradually increasing in China, more than half of the patients are still unable to retain breast due to their condition. For these patients, breast reconstruction surgery is an important means to improve the postoperative breast shape. With the improvement of surgical technology, endoscopic/robotic NSM combined with immediate prosthesis breast reconstruction has been gradually developed. According to previous literature reports, it has good tumor safety and aesthetics, but it is still lack of large-scale prospective results. This project plans to adopt a prospective cohort design, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and prospectively include patients who receive NSM combined with immediate prosthesis reconstruction under endoscopy/robot and conventional surgery from January 1, 2025 to December 31, 2028. The perioperative complications, tumor safety and patient reported outcomes of the two methods were compared.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06748677
- Europe PMC full search
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06748677 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University People's Hospital
- Last refreshed: 7 January 2025
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