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.