Dysphagia Clinical Trial
Official title:
A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings
Verified date | December 2007 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 2006 |
Est. primary completion date | December 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Utah HSC | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | PriCara, Unit of Ortho-McNeil, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence at one year of Schatzki's ring | One year | No | |
Secondary | GERD score at 1,3,6,9,12 month time intervals | one year | No | |
Secondary | Dysphagia score at 1,3,6,9,12 month time intervals | one year | No |
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