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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ROLL | Prior to surgery, an ultrasound-guided localization will be performed and albumin marked with Technetium 99m will be injected close to the tumor and in the subareolar area. During surgery, a specific probe will be used to locate the lesion and sentinel lymph node. |
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| SEED | During diagnostic biopsy or prior to surgery, a magnetic clip will be placed in the breast lesion; during surgery, localization will be performed using a specific probe, while sentinel lymph node localisation, when needed, will be performed even with indocyanine green dye (ICG) or methylene blue dye |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast conservative surgery | Procedure | Every patients with non-palpable breast lesion will undergo to conservative breast surgery after lesion's localization |
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| Measure | Description | Time Frame |
|---|---|---|
| Free-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). | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Excess breast resection | Excess breast resection calculated by the "calculated resection ratio" (CRR) as follow: CRR = total resection volume/optimal resection volume | 3 years |
| Surgery Time | Surgery duration (hours) |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients with non-palpable lesions candidated for surgery
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Istituti Clinici Scientifici Maugeri SpA | Pavia | Lombardy | 27100 | Italy |
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| 3 years |
| Hospitalization days | Number of hospitalization's days | 3 years |
| Complications | Complications occurred after biopsy or surgery | 3 years |
| Reintervention | Reintervention rates | 3 years |
| Cost-effectiveness analysis | Cost-effectiveness analysis in different subgroups | 3 years |
| Follow up | 5-years follow-up outcomes | 5 years after enrollment |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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