Comparison of tumor clipping and marking of skin projection methods in patients undergoing breast-conserving surgery after neoadjuvant chemotherapy: A randomized controlled trial.

BACKGROUND

In patients scheduled for breast-conserving surgery (BCS) after neoadjuvant chemotherapy, the primary mass is marked with a metallic clip. A comparative study was conducted to determine the efficacy and safety of tattoo application as an alternative to this invasive procedure.

METHODS

Forty patients (clip: 20, tattoo: 20) after neoadjuvant chemotherapy, in the group marked with clips, nonpalpable patients were marked with wire, and BCS was performed; in the tattoo group, BCS was performed with the skin containing the tattoo. All statistical analyses was performed using Statistical Package for the Social Sciences version 25.0 (IBM Corp., Armonk). The study was ultimately completed with a total of 40 patients, comprising 20 patients in each group. In comparison to the standard method, the effect size of our study in reducing complications was d = 0.5, and the power was 88%. This power analysis demonstrates that the necessary number of targeted patients has been successfully reached.

RESULTS

There were no significant differences between the groups in terms of demographic and clinicopathological features in the 40 patients included in the study (P > .05). The radiological distance of the tumor to the skin was significantly lower in the group of patients who were marked with the tattoo technique than in the group of patients who underwent clipping (tattoo: 15.7 ± 7.4 vs clip: 20.7 ± 9.5) (P = .045). Reexcision requirement was lower in the tattoo group (35% vs 15%, P = .273). All 4 patients whose surgical margin closeness of the tumor was found to 1 to 2 mm, were in the clip group (P = .106). Complications (hematoma/ecchymosis) were observed in 6 (15%) patients in the clip group, and pain was observed in 5 (12.5%) patients. All patients with complications were included in the clip-marked group. Clip migration was observed in 3 (15%) of the patients. No complications were observed in the tattoo group.

CONCLUSION

Tattooing, which is an alternative to the method of marking the mass with metallic clips (accepted as the standard today) before neoadjuvant treatment, is an easy and inexpensive method with fewer complications.