3554 Dysphagia without endoscopically evident disease: to dilate or not?

Abstract

Background: It is not known whether patients with esophageal dysphagia and a normal EGD benefit from empiric dilation. A retrospective study suggested that such patients do have improvement following empiric dilation with a rigid dilator. We have recently reported that rigid and balloon dilators are equally effective in the treatment of benign lower esophageal strictures. Aim: The aim of this prospective study was to determine if patients with solid food dysphagia and a normal endoscopy have symptom benefit from empiric dilation using a through-the-scope (TTS) balloon. Methods: Patients with normal endoscopic exams at our institution from 1998-1999, with the complaint of lower esophageal solid food dysphagia were identified. Patients were randomized at the time of EGD to either sham or balloon dilation using an 18 mm TTS (Boston Scientific Corp, Microvasive Endoscopy, MA) balloon. All patients completed a dysphagia questionnaire and 10 cm visual analog dysphagia scale prior to endoscopy. Questionnaires were completed at day one, three-months, and six-months post-randomization. The primary endpoint of the study was the patient's self-assessment of difficulty swallowing using the questionnaires.Wilcoxon Rank Sum Test and Fisher's Exact Test were used for statistical analyses. Results: Fifty-four patients (27M; 27F) with a median age of 60 years (range 33-81 yrs) were randomized to either sham (n=26) or balloon (n=28) dilation. The two groups were comparable in age, gender, baseline dysphagia and use of anti-reflux medication. Dysphagia improvement comparing sham/balloon is shown: Day one 54% vs. 77% (p=.144); 3-month 46% vs. 44% (p=.99); 6-month 46% vs. 46% (p=.99). Although the initial response at day one was higher in the balloon group, the difference was not statistically significant. There were no reported complications in either group. Conclusion: The data from this prospective randomized controlled study would, therefore, not support the practice of empiric dilation in patients with lower esophageal solid food dysphagia without evidence of endoscopic causes for dysphagia. Background: It is not known whether patients with esophageal dysphagia and a normal EGD benefit from empiric dilation. A retrospective study suggested that such patients do have improvement following empiric dilation with a rigid dilator. We have recently reported that rigid and balloon dilators are equally effective in the treatment of benign lower esophageal strictures. Aim: The aim of this prospective study was to determine if patients with solid food dysphagia and a normal endoscopy have symptom benefit from empiric dilation using a through-the-scope (TTS) balloon. Methods: Patients with normal endoscopic exams at our institution from 1998-1999, with the complaint of lower esophageal solid food dysphagia were identified. Patients were randomized at the time of EGD to either sham or balloon dilation using an 18 mm TTS (Boston Scientific Corp, Microvasive Endoscopy, MA) balloon. All patients completed a dysphagia questionnaire and 10 cm visual analog dysphagia scale prior to endoscopy. Questionnaires were completed at day one, three-months, and six-months post-randomization. The primary endpoint of the study was the patient's self-assessment of difficulty swallowing using the questionnaires.Wilcoxon Rank Sum Test and Fisher's Exact Test were used for statistical analyses. Results: Fifty-four patients (27M; 27F) with a median age of 60 years (range 33-81 yrs) were randomized to either sham (n=26) or balloon (n=28) dilation. The two groups were comparable in age, gender, baseline dysphagia and use of anti-reflux medication. Dysphagia improvement comparing sham/balloon is shown: Day one 54% vs. 77% (p=.144); 3-month 46% vs. 44% (p=.99); 6-month 46% vs. 46% (p=.99). Although the initial response at day one was higher in the balloon group, the difference was not statistically significant. There were no reported complications in either group. Conclusion: The data from this prospective randomized controlled study would, therefore, not support the practice of empiric dilation in patients with lower esophageal solid food dysphagia without evidence of endoscopic causes for dysphagia.