Balloon Dilation in Selected Subjects with Refractory Eustachian Tube Dysfunction

描述(申请人提供)：咽鼓管(ET)是中耳(ME)和鼻咽(NP)之间潜在的交通工具。ET的管腔通常是闭合的，但可以通过输卵管旁肌肉的活动暂时打开。已知ET开放功能(ETF)在表现为渗出性中耳炎(OME)的患者中受损，结构性ET功能障碍(ETD)可导致疾病作为一种慢性疾病持续存在。在改善ETF或长期解决持续性OME方面，没有标准的药物治疗有效，通常的治疗方法是插入呼吸管(VTS)，绕过ET，保持ME与环境之间的开放沟通。然而，成人VT的功能半衰期约为4-9个月，当VT被挤出或变得无功能时，疾病往往会复发。最近，一种替代的、也许是更永久的外科治疗方法，即球囊扩张ET(BDET)，被描述为相对容易操作、安全和有效地解决OME，并正在积极推广到执业外科医生的实践中。然而，少数几项评估该方法有效性的临床研究包括样本量小，对“治愈”的定义薄弱，并且没有随机、盲目或假对照。重要的是，没有一项研究评估了这一程序对ETF的直接影响。在此，我们建议进行一项初步研究，以确定改善BDET ETF的安全性和有效性。在两年的时间里，我们将确定年龄在18-50岁之间的其他健康患者，他们植入了VTS，作为对ETD引起的OME的治疗。为试验性、单侧BDET提供知情同意的40名患者将被纳入研究对象。他们将进行基线ETF测试和内窥镜ET/NP评估，以证明是否存在ETD。患有ETD的受试者将接受3种可能降低ETF评级的常见疾病的评估：过敏、鼻窦炎和胃-食道反流病。如果诊断出一种情况，受试者将接受适当的医疗治疗；否则，他们将接受鼻内类固醇治疗。ETF测试和鼻内窥镜检查将重复进行，20名对药物治疗无效的ETD患者将在监测麻醉护理下进行单侧BDET。为了安全和测量ET的管腔几何形状，在手术前将对ET和ME进行修改的CT检查。ETF测试和内窥镜评估将在1、3和6个月重复进行，CT扫描将在BDET后3个月重复进行。这些数据将被分析以：确定未选定的OME成人发生ETD的频率和原因；确定是否可以使用针对合并症或炎症的短期治疗来取消受试者的BDET考虑；确定与该过程相关的并发症的类型和频率；描述该过程对ETF和ET管腔几何的影响。这些结果将决定该程序的多中心、II/III期临床试验是否合理。

DESCRIPTION (provided by applicant): The Eustachian tube (ET) is a potential communication between the middle ear (ME) and nasopharynx (NP). The lumen of the ET is usually closed but can be transiently opened by the activity of the paratubal muscles. It is known that the ET opening function (ETF) is impaired in patients presenting with otitis media with effusion (OME) and that constitutive ET dysfunction (ETD) can cause the persistence of the disease as a chronic condition. No standard medical therapy is effective in improving ETF or in resolving persistent OME long-term and the usual treatment is insertion of ventilation tubes (VTs) which bypasses the ET to maintain an open communication between the ME and environment. However, the functional half-life of a VT in adults is approximately 4-9 months and the disease often recurs when the VT is extruded or becomes non-functional. Recently, an alternative and perhaps more permanent surgical treatment for ETD, balloon dilation of the ET (BDET), has been described as being relatively easy to perform, safe and efficacious in resolving OME and is being actively promoted to practicing surgeons for adoption in their practices. However, the few clinical studies that evaluated the efficacy of the procedure included small sample sizes, a weak definition of "cure" and were not randomized, blinded or sham controlled. Importantly, none of the studies evaluated the direct effect of the procedure on ETF. Here, we propose to conduct a pilot study to define the safety and efficacy with respect to improving ETF of BDET. Over a 2-year period, we will identify otherwise healthy patients between 18-50 years of age who have VTs inserted as a treatment for OME caused by ETD. Forty of the patients who provide informed consent for experimental, unilateral BDET will be enrolled as subjects in the study. They will have baseline ETF tests and endoscopic ET/NP evaluations to document the presence or absence of ETD. The subset of subjects with ETD will be evaluated for 3 common conditions that can down-grade ETF: allergy, sinusitis and gastro-esophageal reflux disease. If a condition is diagnosed, the subject will be treated medically as appropriate; otherwise, they will be treated with intranasal steroids. ETF tests and nasal endoscopic examinations will be repeated and 20 subjects with ETD unresponsive to medical treatment will have unilateral BDET done under monitored anesthesia care. For safety and measurement of ET luminal geometry, a modified CT protocol focused on the ET and ME will be done prior to the procedure. ETF tests and endoscopic evaluations will be repeated at 1, 3 and 6 months and the CT scan will be repeated at 3 months after the BDET. The data will be analyzed to: define the frequency and cause of ETD in unselected adults with OME; determine if a short course of medical treatment for co-morbid conditions or for inflammation can be used to disqualify subjects from consideration for BDET, identify the type and frequency of complications associated with the procedure, describe the effect of the procedure on ETF and ET luminal geometry. These results will determine if a multi-center, phase II/III clinical trial ofthe procedure is warranted.