Department of Otolaryngology - Head and Neck Surgery, Sunnybrook Research Institute, Toronto, Canada.
Department of Otolaryngology - Head and Neck Surgery, University of Toronto, Toronto, Canada.
J Otolaryngol Head Neck Surg. 2023 Feb 28;52(1):20. doi: 10.1186/s40463-022-00599-1.
Obstructive eustachian tube dysfunction is a common pathology, generally accepted as the underlying cause for chronic ear diseases. Eustachian tube dilation has shown promising results in randomized controlled trials, but is a costly procedure. The aim of the current study was to assess the feasibility of transnasal balloon dilatation of the eustachian tube with an endovascular balloon in the context of ease of use, maneuverability, and safety.
Clinical pilot study carried out at a university tertiary care facility. In total, twelve patients, were included over a period of 6 months. All patients underwent tympanoplasty or tympanomastoidectomy surgeries. Eustachian tube dilation was carried out transnasal using an endovascular balloon. A computed tomography was carried out after surgery to assess for any potential damages and compared to preoperative imaging studies. Postoperative endoscopy was performed intraoperatively and at follow up to assess for any potential damages.
All eustachian tube dilations were carried out successfully. No severe adverse events were noted during the procedure, in the postoperative period, or on imaging studies. Minor adverse events such as mild intraoperative bleeding was managed in a routine fashion.
Balloon dilation of the eustachian tube with the endovascular balloon was feasible and safe in all cases. It is likely a more cost-effective alternative to commercially available balloons with similar designs and specifications. Trial registration The study was registered at clinicaltrials.gov; NCT04809753, initial release February 24th, 2021.
咽鼓管阻塞是一种常见的病理现象，被普遍认为是慢性耳部疾病的根本原因。在随机对照试验中，咽鼓管扩张已显示出良好的效果，但这是一种昂贵的程序。本研究旨在评估使用血管内球囊经鼻扩张咽鼓管的可行性，包括操作简便性、可操作性和安全性。
在大学三级保健机构进行的临床试点研究。共纳入 12 例患者，在 6 个月的时间内进行。所有患者均行鼓室成形术或乳突切除术。经鼻使用血管内球囊行咽鼓管扩张。术后进行 CT 检查以评估是否存在任何潜在损伤，并与术前影像学研究进行比较。术后内镜检查在术中及随访时进行，以评估是否存在任何潜在损伤。
所有咽鼓管扩张均成功进行。在手术过程中、术后或影像学检查中均未出现严重不良事件。仅出现一些轻微的不良事件，如术中轻度出血，均以常规方式处理。
血管内球囊扩张咽鼓管在所有情况下均是可行且安全的。与具有相似设计和规格的市售球囊相比，它可能是一种更具成本效益的替代方案。
该研究在 clinicaltrials.gov 上注册；NCT04809753，首次发布于 2021 年 2 月 24 日。
