Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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).
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
50 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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