Balloon Dilation in Selected Subjects with Refractory Eustachian Tube Dysfunction

患有难治性咽鼓管功能障碍的特定受试者的球囊扩张

• 批准号: 8634381
• 负责人: Cuneyt Metin Alper
• 金额: $ 22.89万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8634381
• 关键词: Adolescent; Adoption; Adult; Affect; Age-Years; Air; Anesthesia procedures; Balloon Dilatation; Biological; Blinded; Blood; Blood capillaries; Bolus Infusion; Bypass; Caliber; Caring; Cartilage; Child; Chronic; Clinical; Clinical Protocols; Clinical Research; Clinical Trials; Communication; Consent; Data; Development; Diagnosis; Disease; Ear; Economic Inflation; Eligibility Determination; Enrollment; Environment; Environmental air flow; Etiology; Eustachian Tube; Evaluation; Extravasation; Frequencies; Functional disorder; Gases; Gastroesophageal reflux disease; Geometry; Goals; Half-Life; Health; Hypersensitivity; Infant; Inflammation; Informed Consent; Laboratories; Length; Liquid substance; Long-Term Effects; Measurement; Measures; Medical; Monitor; Mucositis; Mucous Membrane; Muscle; Nasopharynx; Nose; Operative Surgical Procedures; Otitis Media with Effusion; Outcome; Outcome Measure; Partial Pressure; Pathogenesis; Pathology; Patient Selection; Patients; Phase; Phase II/III Trial; Physiological; Pilot Projects; Placebo Effect; Play; Population; Procedures; Protocols documentation; Publications; Publishing; Randomized; Refractory; Reporting; Research; Resolution; Role; Safety; Sample Size; Secondary to; Sinusitis; Steroids; Surgeon; Testing; Time; Tube; Tumor Debulking; Tympanic membrane; X-Ray Computed Tomography; capillary; clinical efficacy; design; improved; middle ear; middle ear disorder; pressure; prevent; public health relevance; respiratory; response; screening

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.

描述（由申请人提供）：Eustachian Tube（ET）是中耳（ME）和鼻咽（NP）之间的潜在通信。 ET的腔通常是闭合的，但可以通过副肌肉的活性来暂时打开。众所周知，ET开放函数（ETF）在出现有积液（OME）的中耳炎的患者中受到损害，并且本构ET功能障碍（ETD）可能导致该疾病的持续性作为慢性病。没有标准的医疗疗法可有效改善ETF或长期解决持久性OME，通常的治疗是插入通风管（VTS），该通风管（VTS）绕过ET以维持ME和环境之间的开放通信。但是，成人VT的功能性半衰期约为4-9个月，当VT被挤出或变得无功能时，该疾病通常会复发。最近，一种对ETD的替代性手术治疗，ET的气球扩张（BDET）被描述为相对易于执行，可以安全有效地解决OME，并正在积极促进实践外科医师在其实践中采用。但是，评估该过程疗效的少数临床研究包括小样本量，“治疗”的弱定义，并且不是随机，盲目或虚假控制的。重要的是，没有一项研究评估该程序对ETF的直接影响。在这里，我们建议进行一项试点研究，以定义改善BDET ETF的安全性和功效。在2年的时间里，我们将确定在18-50岁之间的其他健康患者，他们将VT插入为ETD引起的OME治疗。在研究中，将有40名提供实验性同意的患者，单侧BDET作为受试者。他们将进行基线ETF测试和内窥镜ET/NP评估，以记录ETD的存在或不存在。将评估具有ETD受试者的子集的3种常见条件，这些常见条件可以降级ETF：过敏，鼻窦炎和胃 - 食管反流疾病。如果诊断出病情，将在适当的医学治疗中对受试者进行治疗；否则，将用鼻内类固醇治疗它们。将重复ETF测试和鼻内镜检查检查，并在受到监测的麻醉护理下进行单侧BDET，对医疗治疗无反应的受试者将进行单侧BDET。为了确保ET腔几何形状的安全性和测量，将重点介绍ET的修改CT协议将在手术前完成。 ETF测试和内窥镜评估将在1、3和6个月重复，CT扫描将在BDET后3个月重复。将分析数据以：定义未选择的OME成年人ETD的频率和原因；确定是否可以使用短暂的合并状况治疗或炎症治疗，以使受试者不受BDET的考虑，确定与程序相关的并发症的类型和频率，描述该程序对ETF和ET Luminal几何学的影响。这些结果将确定是否有必要进行该程序的多中心，II/III期临床试验。