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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without stricture - dilation with 60-Fr | Active Comparator | Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator |
|
| Without stricture - dilation with 15-Fr | Sham Comparator | Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham) |
|
| Non severe stricture - dilation with 60-Fr | Active Comparator | Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator |
|
| Non severe stricture - dilation with 46-Fr | Active Comparator | Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator |
|
| Severe stricture - dilation with 51-Fr | Active Comparator | Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dilation 60-Fr non stricture | Procedure | Dilation of patients with subjective dysphagia and normal endoscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of study (12 months) |
| Duration of sustained change between sessions |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen McClave, MD | University of Louisville School of Medicine | Principal Investigator |
| Benjamin Rogers, MD | University of Louisville School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States | ||
| UofL health - Jewish hospital downtown |
Planning to share data throughout the intervals for which patients will be called for response and when data available for analysis.
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| Severe stricture - dilation with 42-Fr | Active Comparator | Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator |
|
| Sham | Procedure | Sham dilator for patients with subjective dysphagia and normal endoscopy |
|
| Non severe stricture - dilation with 60-Fr | Procedure | Dilation of non severe stricture with 60-Fr dilator |
|
| Non severe stricture - dilation with 46-Fr | Procedure | Dilation of non severe stricture with 46-Fr dilator |
|
| Severe stricture - dilation with 51-Fr | Procedure | Dilation of a severe stricture with 51-Fr dilator |
|
| Severe stricture - dilation with 42-Fr | Procedure | Dilation of a severe stricture with 42-Fr dilator |
|
| Baseline, "every 8 weeks (for non severe stricture)" "every 4 weeks (for severe stricture)" for 12 months |
| 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. | End of study (12 months) |
Evaluate the average duration between dilation sessions in patients undergoing dilation for non-severe and severe strictures. |
| 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. | Every 8 weeks (for non severe stricture) and every 4 weeks (for severe stricture) for 1 year |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Louisville VA Medical Center | Louisville | Kentucky | 40206 | United States |
| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| D004108 | Dilatation, Pathologic |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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