Several localization techniques are now in use for localization of non-palpable breast lesions. Several studies have compared wire guided localization (WGL), which has been for years the gold standard for non-palpable breast lesions' localization, with more modern techniques. Scientific evidence supports the efficacy of the new "wire-free" techniques, which appear to be comparable to the WGL in terms of safe surgical resection, while overcoming limitations associated with logistic difficulties and patient discomfort. There is still limited data in literature on the comparative effectiveness of these modern techniques, and there is no strong evidence that one is superior to the others. In particular, no randomized trials of comparison between ROLL and magnetic seed localization are currently available. The aim of this randomized study is to compare ROLL with magnetic seed to assess their efficacy for non-palpable breast lesions' localization.
Study Type
OBSERVATIONAL
Enrollment
262
Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization
Istituti Clinici Scientifici Maugeri SpA
Pavia, Lombardy, Italy
RECRUITINGFree-surgical margins
Number of surgical procedures in which surgical margins are disease-free ("no ink on tumor" for invasive cancer and margin of 2 mm for in situ-carcinoma).
Time frame: 3 years
Excess breast resection
Excess breast resection calculated by the "calculated resection ratio" (CRR) as follow: CRR = total resection volume/optimal resection volume
Time frame: 3 years
Surgery Time
Surgery duration (hours)
Time frame: 3 years
Hospitalization days
Number of hospitalization's days
Time frame: 3 years
Complications
Complications occurred after biopsy or surgery
Time frame: 3 years
Reintervention
Reintervention rates
Time frame: 3 years
Cost-effectiveness analysis
Cost-effectiveness analysis in different subgroups
Time frame: 3 years
Follow up
5-years follow-up outcomes
Time frame: 5 years after enrollment
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