Breast Cancer
Conditions
Brief summary
Breast conservative surgery (BCS) is nowadays the standard of care for patients affected by early breast lesions. Screening programmes led to an increase of non-palpable breast lesion detection rates. These patients are often eligible for BCS and an accurate preoperative localization technique for the detection of the lesion is required to guarantee a safe surgical excision. The primary goal of BCS is to obtain a complete resection of the tumor with disease-free surgical margins. The presence of tumor on surgical margins on postoperative histological examination of the specimen increases the risk of local recurrence and it requires a surgical re-excision. For all these reasons different techniques for localization of non-palpable breast lesions have been developed over time. Since '70s the wire guided localization (WGL) technique has represented the gold standard; however it has several limitations such as wire migration or fracture and patient referred discomfort related to wire placement. Over time, other techniques have been proposed, such as the radioguided occult lesion localization (ROLL), radioactive and magnetic seeds, carbon dye and ultrasound-guided preoperative localization. Currently there are several studies of comparison between the WGL and the more modern techniques. All of these data claim the effectiveness of the new wire-free methodics ensuring a safe surgical resection with tumor-free margins and, in some cases, a better aesthetic result. Studies of comparison between the modern techniques are limited. There is no scientific evidence of the superiority of a technique over the other. A multicentric Italian survey demonstrated that the most used localization techniques nowadays are the WGL, ROLL, the magnetic seed and the carbon dye. The aim of this retrospective study is to compare these techniques to assess their efficacy in the localization of non-palpable breast lesions.
Interventions
PROCEDUREBreast conservative surgery
Breast conservative surgery after non-palpable lesion localization
Sponsors
Istituti Clinici Scientifici Maugeri SpA
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Inclusion criteria
* Female sex; * Patients who underwent breast conservative surgery for non-palpable occult breast lesions; * Intraoperative localization of breast lesion with WGL, ROLL, magnetic seed, carbon dye; * Preoperative diagnosis on histology or cytology of borderline lesion (B3 or C3) or malignant lesion (B4-B5 or C4-C5).
Exclusion criteria
* Diagnosis of benign breast lesion, both on preoperative needle breast biopsy (B2) or on fine needle breast aspiration (C2); * Clinically palpable breast lesion; * Localization of a non-palpable lesion through two or more different techniques; * Breast tumor localization with clip in patients who underwent neoadjuvant chemotherapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free-surgical margins | 6 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reintervention | 6 months | Reintervention rates |
| Follow up | 5 years after enrollment | 5-years follow-up outcomes |
| Complications | 6 months | Complications (after biopsy or surgery) |
| Surgery time | 6 months | Surgery duration |
| Hospitalization days | 6 months | Number of hospitalization days |
| Excess breast resection | 6 months | Excess breast resection calculated by the calculated resection ratio (CRR=total resection volume/optimal resection volume) |
Countries
Italy
Outcome results
None listed