Department of Otolaryngology-Head and Neck Surgery, Weill Cornell Medical College, New York, New York, USA.
Laryngoscope. 2012 Apr;122(4):718-23. doi: 10.1002/lary.23181. Epub 2012 Feb 28.
OBJECTIVES/HYPOTHESIS: The surgical management options for eustachian tube dysfunction have historically been limited. The goal of the current study was to evaluate the technical considerations, learning curve, and potential barriers for balloon dilation of the eustachian tube (BDET) as an alternative treatment modality.
Prospective preclinical trial of BDET in a cadaver model.
A novel balloon catheter device was used for eustachian tube dilation. Twenty-four BDET procedures were performed by three independent rhinologists with no prior experience with the procedure (eight procedures per surgeon). The duration and number of attempts of the individual steps and overall procedure were recorded. Endoscopic examination of the eustachian tube was performed after each procedure, and the surgeon was asked to rate the subjective difficulty on a five-point scale.
Successful completion of the procedure occurred in each case. The overall mean duration of the procedure was 284 seconds, and a mean number of 1.15 attempts were necessary to perform the individual steps. The mean subjective procedure difficulty was noted as somewhat easy. Statistically shorter duration and subjectively easier procedure were noted in the second compared to the first half of the series, indicating a favorable learning curve. Linear fissuring within the eustachian tube lumen without submucosal disruption (nine procedures, 37%) and with submucosal disruption (five procedures, 21%) were noted. The significance of these physical findings is unclear.
Preclinical testing of BDET is associated with favorable duration, learning curve, and overall ease of completion. Clinical trials are necessary to evaluate safety and efficacy.
目的/假设： 先天性耳前瘘管的手术治疗选择历来有限。本研究的目的是评估球囊扩张咽鼓管（BDET）作为替代治疗方法的技术考虑因素、学习曲线和潜在障碍。
在尸体模型中进行 BDET 的前瞻性临床前试验。
使用新型球囊导管装置进行咽鼓管扩张。由三位没有该手术经验的独立鼻科医生（每位医生进行 8 例）进行 24 例 BDET 手术。记录各个步骤的持续时间和尝试次数以及整个手术的持续时间和尝试次数。每次手术后对咽鼓管进行内镜检查，并要求外科医生对主观难度进行五分制评分。
每个病例均成功完成手术。该手术的总平均持续时间为 284 秒，完成各个步骤平均需要尝试 1.15 次。平均主观手术难度被认为是有些容易。与前半部分相比，后半部分手术的持续时间更短，主观上更容易，表明存在有利的学习曲线。在九个手术中（37%），发现了咽鼓管管腔中的线性裂伤，没有黏膜下破坏，而在五个手术中（21%）则存在黏膜下破坏。这些物理发现的意义尚不清楚。
BDET 的临床前测试与有利的持续时间、学习曲线和整体完成难度相关。需要进行临床试验来评估安全性和疗效。
