DILATATION THERAPY FOR PHARYNGEAL DYSPHAGIA

描述(取自应用程序) 这项随机前瞻性临床试验的长期目标是 提供大直径扩张器通过的证据 继发于咽部吞咽困难的进食障碍患者。一个坚强的人 吞咽功能改善与测压变化的关系 参数已在初步研究中显示。因为这位亲戚 大多数咽部吞咽困难患者缺乏特效治疗， 作为经验性治疗的大直径扩张器已被用于 多年的临床医生。文献中没有一项研究提供客观的 该疗法的应用标准、疗效评价或 它的成功率的迹象。一个潜在的原因是缺乏 UES扩张术在咽部疾病中的应用 吞咽困难是缺乏一种客观的技术来识别 适当的患者，并提供治疗评估。这个 改进的可重复性咽部和咽部测量技术的发展 吞咽时的UES压力可以对这些压力进行定量评估 功能，以便可以识别压力动态的细微变化并 分类的。所有患者都将首先接受体检， 头颈部综合评估，纤维喉镜检查， 视频荧光素吞咽检查(VFSS)和咽部/UES测压。 如果患者的测压研究表明，他们将被视为候选人 UES静息压升高、UES残余压升高或衰减 UES松弛持续时间并将其随机分为两组。第I组 将接受柔性食道镜检查并扩张至60法式探条 扩张器。第二组将接受软性食管镜检查，并通过15F 扩张器。两组患者将在3个月后重新评估。 II组的患者继续有症状并表现出 异常测压将被忽略。所有患者都将接受重新评估 每隔3个月进行一次。咽部/UES测压将在1岁时重复。 研究将由一名对实际治疗视而不见的研究人员进行评估。 症状反应(吞咽困难问卷)和客观反应 (测压结果)将进行评估。这项研究的目标是 对50例患者(每组25例)在扩张后12个月进行评估。它 据估计，完成这项研究的50名患者的应计利润 协议将在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.