The purpose of this study is to better understand the role of a technique called esophageal dilation in patients who complain of trouble swallowing. In patients with esophageal stricture we want to determine if the size of the esophageal dilator makes a difference in symptoms and outcomes. In patients who do not have an obvious esophageal stricture we want to determine if esophageal dilation is an effective therapy in these patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
34
Dilation of patients with subjective dysphagia and normal endoscopy
Sham dilator for patients with subjective dysphagia and normal endoscopy
Dilation of non severe stricture with 60-Fr dilator
University of Louisville Hospital
Louisville, Kentucky, United States
UofL health - Jewish hospital downtown
Louisville, Kentucky, United States
Louisville VA Medical Center
Louisville, Kentucky, United States
Change in subjective symptoms of dysphagia in patients without strictures undergoing empiric dilation. As measured by dysphagia score.
Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) in patients without strictures undergoing empiric dilation.
Time frame: Baseline, every 8 weeks for 12 months
Change in ability to tolerate diet in patients without strictures undergoing empiric dilation. As measured by diet score.
Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) in patients without strictures undergoing empiric dilation.
Time frame: Baseline, every 8 weeks for 12 months
Change in subjective symptoms of dysphagia in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by dysphagia score.
Evaluate the change in dysphagia (the dysphagia score is used to assess for severity of dysphagia, score ranges from 0 to 5 with the higher score indicates greater degree of severity) in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture.
Time frame: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Change in ability to tolerate diet in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture. As measured by diet score.
Evaluate the change in diet score (the diet score is used to assess the ability of the patient to tolerate food, score ranges from 0 to 5 with the higher score indicates inability to eat) in patients with strictures undergoing dilation with 60-Fr vs 46-Fr for non severe stricture, and 51-Fr vs 42-Fr for severe stricture.
Time frame: Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
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Dilation of non severe stricture with 46-Fr dilator
Dilation of a severe stricture with 51-Fr dilator
Dilation of a severe stricture with 42-Fr dilator
Achievement of complete relief of dysphagia
Evaluate the number of patients in each study arm that achieve complete relief of dysphagia for the remainder of the study.
Time frame: End of study (12 months)
Dilation sessions required to achieved sustainable change in dysphagia and diet score
Evaluate the number of dilation sessions needed to achieve sustainable change in dysphagia and diet scores in patients with non-severe and severe stricture.
Time frame: End of study (12 months)
Duration of sustained change between sessions
Evaluate the average duration between dilation sessions in patients undergoing dilation for non-severe and severe strictures.
Time frame: Every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months
Reduction of more than 3 sizes dilators in subsequent dilation sessions to achieve the goal dilation
Evaluate if more than 3 size reduction from target diameter is needed as a result of tactile resistance for subsequent dilation sessions in patients undergoing dilation for non-severe and severe stricture.
Time frame: Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year