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NCT04461847
ESM Versus OM :A Randomized Controlled Trial
NA trial testing subcutaneous mastectomy in Endoscopic Subcutaneous Mastectomy in 287 participants. Status unknown.
31 December 2022
Quick facts
| Lead sponsor | Beijing Friendship Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 287 |
| Start date | 1 December 2020 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 1 location across China |
Drugs / interventions tested
- subcutaneous mastectomy
- endoscopic subcutaneous mastectomy
Conditions studied
- Endoscopic Subcutaneous Mastectomy — all drugs for Endoscopic Subcutaneous Mastectomy →
Sponsor
Beijing Friendship Hospital
Who can join
Adults 18 to 70, female only, with Endoscopic Subcutaneous Mastectomy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The consideration of quality of life issues has led to the development of alternative surgeries for breast cancer patients, particularly in the case of localized disease. Nipple-sparing subcutaneous mastectomy (SM), for example, was designed to preserve the nipple-areola complex which facilitates breast reconstruction. However, SM still leaves behind a conspicuous scar.There have already been some observation study show that endoscopic subcutaneous mastectomy(ESM) can improve the cosmesis outcomes and at the same time as safe as the traditional SM.However there is no RCT in this field.That is why the investigators design this study.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Single-port insufflation endoscopic nipple-sparing mastectomy in early breast cancer: a retrospective cohort study.
Liu WH, Wu SS, Tian YM, Liu J, et al · · 2023 · cited 4× · PMID 38021192 · DOI 10.21037/gs-23-148 -
Oncological outcome of single-port insufflation endoscopic nipple-sparing mastectomy versus open mastectomy in early breast cancer patients: a study protocol for a randomised controlled trial.
Wang ZH, Ding G, Wu S, Song JN, et al · · 2022 · cited 1× · PMID 35501091 · DOI 10.1136/bmjopen-2020-047866
Verify or expand the search:
- PubMed search for NCT04461847
- 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 NCT04461847 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beijing Friendship Hospital
- Last refreshed: 1 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04461847.
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