Safety and efficacy of a nonionic water-soluble iodinated contrast medium for videofluoroscopic swallowing studies

Objectives: This study evaluated the safety and efficacy of an iodinated contrast agent for videofluoroscopic swallowing studies (VFSS) in patients with swallowing disorders, compared with barium sulfate contrast agents. Methods: The study included 20 patients who underwent VFSS at Hiroshima University Hospital in 2025 for dysphagia evaluation. Iodixanol (Visipaque 270®; GE Healthcare Pharma Co., Ltd., Chicago, Illinois) was used as the iodinated contrast agent. For comparison, VFSS images obtained with Barytester® (FUSHIMI Pharmaceutical Co., Ltd., Kagawa, Japan) in the same patients served as barium sulfate controls. The frequency of adverse events associated with oral Visipaque 270® administration was assessed. VFSS images obtained with Barytester® and Visipaque 270® in the same patients were compared to evaluate imaging performance. To determine whether image evaluation outcomes were equivalent between Visipaque 270® and Barytester®, an equivalence test was performed using the two one-sided tests procedure. Results: Visipaque 270® was associated with no adverse events, including gastrointestinal or other adverse events. Image evaluations using Visipaque 270® and Barytester® were statistically equivalent. Conclusions: VFSS was performed using the iodinated contrast agent Visipaque 270®. No adverse events related to oral Visipaque 270® administration were observed, and contrast enhancement on VFSS images was comparable to that achieved with Barytester®. Trial registration: Japan Registry of Clinical Trials, jRCTs061240040; registered 26 July, 2024.