Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings

Study Overview
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Brief Summary
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The primary objective of this study is to compare the efficacy of bougie dilation to electrosurgical incision of symptomatic schatzki's rings at one year follow-up in the presence of rabeprazole treatment. All patients will be followed for one year for recurrence and/or severity of dysphagia and will be placed on rabeprazole for that time period.

Detailed Description
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Fifty consecutive patients referred for endoscopic evaluation at endoscopy labs at the University of Utah Health Sciences Center and the Salt Lake City VA Medical Center for dysphagia will be enrolled in the study prior to endoscopy. If a Schatzki's Ring is found at endoscopy, the patient will be randomized to electrosurgical incision or standard bougie dilation. Patients will be placed on rabeprazole for one year. Follow-up on recurrence and/or severity of dysphagia will be analyzed at interim time periods (1,3,6, 9 12 months).

Official Title
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A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings

Conditions
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Lower Esophageal Ring, Dysphagia

Intervention / Treatment
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* Procedure: Bougie Dilation
* Procedure: Needle-knife incision


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between the ages of 18-80 with symptomatic Schatzki's ring No history of bleeding diathesis or other contraindication to bougie dilation or electrosurgical incision Exclusion Criteria: Contraindication to proton pump inhibitors Pregnancy Inability to provide informed consent History of previous esophagogastric surgery Presence of esophageal peptic stricture, esophageal motility disorder or esophageal cancer that could otherwise account for dysphagia Nasopharyngeal lesion or nasal intubation intolerance causing inability to undergo esophageal motility testing and ambulatory pH monitoring

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Bougie dilation | Procedure: Bougie Dilation<br>* Bougie dilation will be performed as standard<br>* Other names: Maloney dilation;|
| Experimental: 2<br>Needle-knife incision | Procedure: Needle-knife incision<br>* Needle-knife incision will be performed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence at one year of Schatzki's ring |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GERD score at 1,3,6,9,12 month time intervals |  | one year | 
| Dysphagia score at 1,3,6,9,12 month time intervals |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lower esophageal ring, dysphagia, electrosurgical incision, bougie dilation, GERD