Pragmatic Approach To Esophageal Dilation

Study Overview
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Brief Summary
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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.

Official Title
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Pragmatic Approach To Esophageal Dilation

Conditions
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Dysphagia, Swallowing Disorders

Intervention / Treatment
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* Procedure: Dilation 60-Fr non stricture
* Procedure: Sham
* Procedure: Non severe stricture - dilation with 60-Fr
* Procedure: Non severe stricture - dilation with 46-Fr
* Procedure: Severe stricture - dilation with 51-Fr
* Procedure: Severe stricture - dilation with 42-Fr


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with esophageal dysphagia who are 18 years old or older. Patients with dysphagia undergoing Esophagogastroduodenoscopy (EGD). Patients who are able to provide consent for the study. Patients with known esophageal stricture that may have or may not have been dilated before. Exclusion Criteria: Patients with malignant stricture. Pregnant women. Patients with a personal history of esophageal perforation. Patients with achalasia, or globus sensation. Any accessory procedures, like esophageal stenting, excision, steroid injection, or dysphagia treatment currently being done at outside facility.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Without stricture - dilation with 60-Fr<br>Patients without stricture on upper endoscopy will receive empiric dilation with 60-Fr dilator | Procedure: Dilation 60-Fr non stricture<br>* Dilation of patients with subjective dysphagia and normal endoscopy<br>|
| Sham Comparator: Without stricture - dilation with 15-Fr<br>Patients without stricture on upper endoscopy will receive empiric dilation with 15-Fr dilator (sham) | Procedure: Sham<br>* Sham dilator for patients with subjective dysphagia and normal endoscopy<br>|
| Active Comparator: Non severe stricture - dilation with 60-Fr<br>Patients with non-severe stricture on upper endoscopy will receive dilation with 60-Fr dilator | Procedure: Non severe stricture - dilation with 60-Fr<br>* Dilation of non severe stricture with 60-Fr dilator<br>|
| Active Comparator: Non severe stricture - dilation with 46-Fr<br>Patients with non-severe stricture on upper endoscopy will receive dilation with 46-Fr dilator | Procedure: Non severe stricture - dilation with 46-Fr<br>* Dilation of non severe stricture with 46-Fr dilator<br>|
| Active Comparator: Severe stricture - dilation with 51-Fr<br>Patients with severe stricture on upper endoscopy will receive dilation with 51-Fr dilator | Procedure: Severe stricture - dilation with 51-Fr<br>* Dilation of a severe stricture with 51-Fr dilator<br>|
| Active Comparator: Severe stricture - dilation with 42-Fr<br>Patients with severe stricture on upper endoscopy will receive dilation with 42-Fr dilator | Procedure: Severe stricture - dilation with 42-Fr<br>* Dilation of a severe stricture with 42-Fr dilator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dysphagia, Swallowing Disorders, Empirical dilation, Dilation, Dysphagia score, Diet score