Randomized control trial of fluorescence-guided surgical excision of nonmelanotic cutaneous malignancies

Abstract

Objective: Protoporphyrin IX (PpIX) is an endogenous photosensitizer commonly used in photodynamic therapy. This study sought to assess if PpIX fluorescence can be applied clinically to improve the delineation and excision of nonmelanotic cutaneous malignancies.

Design: Prospective, randomized control trial.

Setting: A tertiary care skin cancer clinic.

Methods: Fifty-one individuals with 65 cutaneous nonmelanotic cervicofacial malignancies were randomized into two groups. The control group was offered surgical excision with surgeon-delineated excision margins. The study group had their excision margins delineated while under fluorescence.

Main outcome measures: The delineated lesion borders, proposed excision margins, and projected lesion-free areas were compared among the two groups. Pathologic resection margins and completeness of excision were also assessed.

Results: Excisions performed using fluorescence delineation were 20% narrower (p < .01) and 17% shorter (p < .04), with 35% less lesion-free skin excised (p < .005). All lesions excised using photodelineation had clear pathologic resection margins. A significant number of lesions excised via the traditional approach required reexcision owing to pathologically positive peripheral margins (p < .001). Follow-up at 2 years revealed no lesion recurrence among the study group and one recurrence within the control group.

Conclusion and significance: The results demonstrate a reliable and novel application for photodynamic photodelination and support its application in the excision of nonmelanotic cutaneous malignancies.