A Prospective Randomized Trial Comparing Radioguided Occult Lesion Localization (ROLL) and Magnetic Seed Localization for the Localization of Nonpalpable Breast Lesions: Analysis of Surgical Outcomes, Patient's Perception, and Costs.

Summary

In a single-center RCT (n=260), magnetic seed localization was noninferior to ROLL for negative margins, with identical resection ratios and similar complication rates but more hematomas. MSL shortened hospital stay and was cost-saving across subgroups, supporting wire-free adoption in breast-conserving surgery.

Key Findings

• Margin negativity: ROLL 97.7% vs MSL 93.1% (p=0.14), meeting noninferiority.
• Calculated resection ratio identical at 1.7 (p=0.61).
• Overall complications similar (6.2% MSL vs 4.7% ROLL, p=0.59); postlocalization hematoma higher with MSL (17% vs 7%, p=0.01).
• Hospital stay shorter with MSL (median 1 vs 2 days, p=0.001).
• MSL was cost-saving across all analyzed subgroups; most EQ-5D-5L domains similar except 'usual activities' favoring ROLL.

Clinical Implications

MSL can be considered a first-line wire-free option when radiotracer logistics are limiting, with counseling on higher hematoma risk and protocols to mitigate it; institutions may realize shorter stays and cost savings.

Limitations

• Single-center design limits generalizability.
• Lack of blinding and perioperative focus without long-term follow-up.

Future Directions

Multicenter, longer-term RCTs should assess cosmetic outcomes, reoperation, and hematoma mitigation strategies; implementation studies can evaluate workflow and equity impacts.