DILATATION THERAPY FOR PHARYNGEAL DYSPHAGIA

描述（摘自应用程序） 这项随机前瞻性临床试验的长期目标是 提供证据证明大直径扩张器的通过有效 继发于咽部吞咽困难的进食障碍患者。 一个强大 与吞咽功能改善和测压变化相关 参数已在初步研究中显示。 因为相对 大多数咽部吞咽困难患者缺乏特异性治疗， 大直径扩张器的通道作为经验性治疗已经被 临床医生多年来 文献中没有研究提供客观的 该疗法的应用标准，其效果的评价或 显示了它的成功率。 一个潜在的原因是缺乏 关于UES扩张在咽部疾病患者中使用的信息 吞咽困难一直缺乏一种客观的技术来识别 合适的患者，并提供治疗评估。 的 改进的可重复技术的发展，用于测量咽和 吞咽期间的UES压力允许定量评估这些 功能，以便可以识别压力动态的细微变化， 分类。 所有患者最初将接受体格检查， 头颈部综合评估，纤维喉镜检查， 视频荧光吞咽研究（VFSS）和咽/UES测压。 如果患者的测压研究显示 UES静息压升高、UES残余压升高或减弱 UES松弛持续时间，并将其随机分为两组。 组I 将接受柔性食管镜检查和扩张到60 French探条 扩张器 第二组将接受柔性食管镜检查，通过15 F 扩张器 两组患者将在3个月时重新评估。 组II中持续有症状并显示 异常测压将被交叉。 所有患者都将接受重新评估 每3个月一次。 将在1年时重复进行咽部/UES测压。 研究将由对实际治疗设盲的研究者进行评价。 症状缓解（吞咽困难问卷）和客观缓解 （测压结果）进行评价。 本研究的目的是 在扩张后12个月内评价50例患者（每组25例）。 它 估计有50名患者完成了这项研究， 方案将在18-24个月内完成。

DESCRIPTION (Taken from application) The long range objective of this randomized prospective clinical trial is to provide evidence that passage of a large diameter dilator is effective in patients with eating disorders secondary to pharyngeal dysphagia. A strong association with improvement in swallow function and change in manometric parameters has been shown in a preliminary study. Because of the relative lack of specific therapy for most patients with pharyngeal dysphagia, passage of a large diameter dilator as empiric treatment has been used by clinicians for many years. No studies in the literature provide objective criteria for the application of this therapy, evaluation of its effect or indications of its success rate. One potential reason for the lack of information on the use of UES dilatation in patients with pharyngeal dysphagia has been the absence of an objective technique to identify appropriate patients and provide an assessment of the treatment. The development of improved reproducible techniques for measuring pharyngeal and UES pressures during swallowing allows a quantitative assessment of these functions so that subtle changes in pressure dynamics can be identified and categorized. All patients will initially undergo physical examination, comprehensive head and neck evaluation, fiberoptic laryngoscopy, videofluorsocpic swallowing study (VFSS) and pharyngea/UES manometry. Patients will be considered candidates if their manometric studies show elevated UES resting pressure, elevated UES residual pressure, or attenuated UES relaxation duration and will be randomized into two groups. Group I will undergo flexible esophagoscopy and dilatation to a 60 French bougie dilator. Group II will undergo flexible esophagoscopy with passage of a 15F dilator. Patients in both groups will be re-evaluated at 3 months. Patients in Group II that continue to be symptomatic and demonstrate abnormal manometry will be crossed over. All patients will be re-evaluated at 3 month intervals. Pharyngeal/UES manometry will be repeated at 1 year. Studies will be evaluated by an investigator blinded to actual treatment. Symptomatic response (dysphagia questionnaires) and objective response (manometric findings) will be evaluated. The goal of this study is to evaluate 50 patients (25 in each group) over 12 months after dilatation. It is estimated that accrual of the 50 patients to complete the research protocol will be accomplished over 18-24 months.