Randomized Controlled Trial Comparing Magnetic Marker Localization (Mamaloc) With Wire-Guided Localization In The Treatment Of Early-Stage Breast Cancer

Gerson M Struik,Bram Schermers, Ingeborg Mares, Harold E Lont, Jennifer W Bradshaw,Bernard Ten Haken,Theo J M Ruers, Jurgen E M Mourik,Erwin Birnie,Taco M A L Klem

BREAST JOURNAL(2021)

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摘要
Wire-guided localization (WGL) is the standard of care in the surgical treatment of nonpalpable breast tumors. In this study, we compare the use of a new magnetic marker localization (MaMaLoc) technique to WGL in the treatment of early-stage breast cancer patients. Open-label, single-center, randomized controlled trial comparing MaMaLoc (intervention) to WGL (control) in women with early-stage breast cancer. Primary outcome was surgical usability measured using the System Usability Scale (SUS, 0-100 score). Secondary outcomes were patient reported, clinical, and pathological outcomes such as retrieval rate, operative time, resected specimen weight, margin status, and reoperation rate. Thirty-two patients were analyzed in the MaMaLoc group and 35 in the WGL group. Patient and tumor characteristics were comparable between groups. No in situ complications occurred. Retrieval rate was 100% in both groups. Surgical usability was higher for MaMaLoc: 70.2 +/- 8.9 vs. 58.1 +/- 9.1, p < 0.001. Patients reported higher overall satisfaction with MaMaLoc (median score 5/5) versus WGL (score 4/5), p < 0.001. The use of magnetic marker localization (MaMaLoc) for early-stage breast cancer is effective and has higher surgical usability than standard WGL.
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关键词
breast carcinoma, magnetism, nonradioactive, patient satisfaction, surgery, surgical usability, trial registration, tumor localization
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