A Scoping Review of Ongoing Fluorescence-Guided Surgery Clinical Trials in Otolaryngology.

Abstract

OBJECTIVE\nFluorescence-guided surgery (FGS) is a rapidly developing intraoperative technology, and many contrast agents are currently under investigation. We sought to provide a review of the current state of FGS clinical trials in Otolaryngology, emphasizing its oncologic applications.\n\n\nMETHODS\nAccording to the preferred reporting Items for systematic reviews and meta-analyses (PRISMA) workflow for scoping reviews, a clinical trial search was performed across multiple international clinical trials registries, searching for permutations of fluorescence, tumor, surgery, and nerve to identify all relevant studies. Studies that were active, enrolling, or soon to be enrolling patients undergoing head and neck surgery were included.\n\n\nRESULTS\nNineteen studies were eligible for inclusion. Seventeen studies are focused on FGS for oncologic resection and lymph node detection. One study assesses peripheral nerve fluorescence, and one evaluates normal parathyroid function after thyroidectomy. Contrast agents under development are conjugated to fluorophores that excite in the 800\u2009nm (indocyanine green), 410\u2009nm (5-aminolevulinic acid), 700\u2009nm (Cyanine 5.5), and 525\u2009nm ranges (fluorescein derivatives).\n\n\nCONCLUSION\nPresently, there are 19 ongoing trials investigating novel FGS contrast agents for their safety, efficacy, and utility in Otolaryngology-Head and Neck Surgery. These agents rely on unique fluorophores and absorption ranges in the near-infrared and visible light spectra. FGS studies are expanding within Otolaryngology-Head and Neck Surgery with profound implications in oncologic surgery, lymph node detection, and anatomic and functional assessment. Laryngoscope, 2021.