Radioguided occult lesion localization versus wire-guided localization for non-palpable breast lesions: randomized controlled trial

Abstract

AIM:This prospective randomized clinical study was conducted to compare radioguided occult lesion localization (ROLL) with wire-guided localization to evaluate optimum localization techniques for non-palpable breast lesions.METHODS:A total of 108 patients who were undergoing an excisional biopsy for non-palpable breast lesions requiring pathologic diagnosis were randomly assigned to the ROLL group (n = 56) and wire-guided localization group (n = 52). In the study, patients' characteristics, radiological abnormalities, radiological technique of localization, localization time, operation time, weight of the excised specimen, clearance margins, pathological diagnosis and perioperative complications were assessed.RESULTS:There were no differences between the two groups in terms of age, radiological abnormalities and localization technique (p = non-significant for all). ROLL techniques resulted in 100% retrieval of the lesions; for the wire-guided localization technique, 98%. Both localization time and operation time were significantly reduced with the ROLL technique (p = significant for all). The weight of the specimen was significantly lower in the ROLL group than in the wire-guided localization group (p = significant). The overall complication rate and pathological diagnosis were similar for both groups (p = non-significant for all). Clear margins were achieved in 91% of ROLL patients and in 53% of wire-guided localization patients, and the difference was significant.CONCLUSIONS:The present study indicated that the ROLL technique is as effective as wire-guided localization for the excision of non-palpable breast lesions. In addition, ROLL improved the outcomes by reducing localization and operation time, preventing healthy tissue excision and achieving clearer margins.

Wire-guided Localization Biopsy to Determine Surgical Margin Status in Patients with Non-palpable Suspicious Breast Lesions

“…The oriantation of the surgeon on macroscopic margins is difficult if there is trouble in determining the depth and localization of the lesion. In centers where this approach has been employed as a definitive therapeutic procedure, 41-60% of patients require no further local surgery, which results in lower costs and morbidity (Saarela et al, 2001;Ocal et al, 2011;Sajid et al, 2012). However, as there is heterogeneity of study designs and endpoints as well as small study sample sizes in literature, the range of the rates vary so widely.…”

Surgical treatment of nonpalpable primary invasive and in situ breast cancer

“…[20][21][22][23]44,49,50 The small cohort sizes and the lack of power calculations for sample sizes also weakened the conclusions from these studies. 20,21,44,49,50 Despite the aforementioned limitations, a metaanalysis of the seven RCTs identified a significant difference between the two techniques, favouring use of RGL for shorter operating times (mean difference [MD] −2.95; 95% CI −4.43 to −1.47; P <0.0001), but at the expense of a significantly greater volume of tissue excised (MD 6.79; 95% CI 0.03−13.56; P = 0.05). 51 A greater volume of tissue excised in breast-conserving surgery has been demonstrated to be detrimental to cosmetic outcome when greater than 10% of the estimated breast volume is removed.…”

“…18,19 Technical issues arising intraoperatively include potential needlestick injuries, diathermy burns, and limitations in incision placement with an adverse effect on cosmetic outcome; 16 indeed, the wire is inserted for optimal radiological positioning of the tumour location and not for ease of surgical excision. Re-operation rates for incomplete tumour excision with WGL surgery are reported to range between 10% and 43% for invasive and in situ disease, [20][21][22][23] compared with an accepted rate of 20% in breast-conserving surgery. 24 The re-operation rates were not assessed when WGL originally emerged, owing to the low importance of this outcome measure in assessing a technique that was, at the time, used for diagnostic biopsy rather than definitive treatment.…”

“…To date, however, only seven randomized controlled trials (RCTs) have been conducted comparing radioguided localization and WGL (Table 1), [20][21][22][23]44,49,50 which all had methodological limitations. These limitations included the absence of preoperative histopathological diagnoses, 20,21,49,50 which resulted in the techniques being used for the purposes of excision biopsy. Thus, assessment of the oncological outcomes (such as involved margins and re-excision rates) was complicated because cohorts included both diagnostic excisions and therapeutic resections.…”

A cosmesis outcome substudy in a prospective, randomized trial comparing radioguided seed localization with standard wire localization for nonpalpable, invasive, and in situ breast carcinomas

“…Other limitations of wire-localized BCS include patient discomfort/anxiety and scheduling limitations (ie, the wire must be placed the day of the operation, necessitating the co-ordination of operative and radiology schedules). 20 Radioguided seed localization (RSL) involves preoperative insertion of a radio-opaque titanium seed containing I 125 into the tumor under stereotactic or ultrasound guidance. A handheld gamma probe is then used to guide intraoperative identification and surgical resection of the tumor.…”