DILATATION THERAPY FOR PHARYNGEAL DYSPHAGIA

描述（取自申请表）

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.