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NCT04461847

ESM Versus OM :A Randomized Controlled Trial

Status unknown NA Last updated 1 December 2020
What this trial tests

NA trial testing subcutaneous mastectomy in Endoscopic Subcutaneous Mastectomy in 287 participants. Status unknown.

Timeline
1 December 2020
Primary endpoint
31 December 2022
31 December 2022

Quick facts

Lead sponsorBeijing Friendship Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment287
Start date1 December 2020
Primary completion31 December 2022
Estimated completion31 December 2022
Sites1 location across China

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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

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Other Beijing Friendship Hospital trials

Trials by the same sponsor.

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