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| Name | Class |
|---|---|
| PriCara, Unit of Ortho-McNeil, Inc. | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Bougie dilation |
|
| 2 | Experimental | Needle-knife incision |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bougie Dilation | Procedure | Bougie dilation will be performed as standard |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence at one year of Schatzki's ring | One year |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Fang, M.D. | University of Utah HSC | Study Director |
| James A DiSario, M.D. | University of Utah HSC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah HSC | Salt Lake City | Utah | 84132 | United States |
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| ID | Term |
|---|---|
| C562765 | Esophageal Ring, Lower |
| D003680 | Deglutition Disorders |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| Needle-knife incision | Procedure | Needle-knife incision will be performed |
|
| D010038 | Otorhinolaryngologic Diseases |
| D015154 | Esophageal Motility Disorders |