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NCT04037852: RCENSM-P

Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer-Prospective Study

Status unknown NA Last updated 13 September 2021
What this trial tests

NA trial testing robotic assisted nipple sparing mastectomy in Breast Cancer Female in 180 participants. Status unknown.

Timeline
1 October 2019
Primary endpoint
31 December 2021
28 February 2022

Quick facts

Lead sponsorChanghua Christian Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment180
Start date1 October 2019
Primary completion31 December 2021
Estimated completion28 February 2022
Sites11 locations across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Changhua Christian Hospital

Who can join

Adults 20 to 70, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study will prospectively evaluate the surgical outcomes of robotic nipple sparing mastectomy (NSM) compared with endoscopic assisted NSM or conventional NSM in the management of breast cancer. One-third patients would received R-NSM, another one-third received C-NSM while the other one-third would receive E-NSM.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Robotic Versus Conventional or Endoscopic-assisted Nipple-sparing Mastectomy and Immediate Prosthesis Breast Reconstruction in the Management of Breast Cancer: A Prospectively Designed Multicenter Trial Comparing Clinical Outcomes, Medical Cost, and Patient-reported Outcomes (RCE
    Lai HW, Chen DR, Liu LC, Chen ST, et al · · 2024 · cited 31× · PMID 37226826 · DOI 10.1097/sla.0000000000005924
  2. Mastectomy with Reconstruction Including Robotic Endoscopic Surgery (MARRES): a prospective cohort study of the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) and Korean Breast Cancer Study Group (KBCSG).
    Ryu JM, Lee J, Lee J, Ko B, et al · · 2023 · cited 19× · PMID 37344780 · DOI 10.1186/s12885-023-10978-0
  3. Consensus Statement on Robotic Nipple Sparing Mastectomy Expert Panel.
    Ryu JM, Mok CW, Toesca A, Lai HW, et al · · 2025 · cited 4× · PMID 40432351 · DOI 10.4048/jbc.2025.0030

Verify or expand the search:

Other recruiting trials for Breast Cancer Female

Currently open trials in the same condition.

Other Changhua Christian Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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