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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2006

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).

Intervention(s) in this Clinical Trial

• Procedure: Bougie Dilation
  • Bougie dilation will be performed as standard
• Procedure: Needle-knife incision
  • Needle-knife incision will be performed

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Bougie dilation
• Experimental: 2
  • Needle-knife incision

Primary Measures

• Recurrence at one year of Schatzki's ring
  • Time Frame: One year
    Safety Issue?: No

Secondary Measures

• GERD score at 1,3,6,9,12 month time intervals
  • Time Frame: one year
    Safety Issue?: No
• Dysphagia score at 1,3,6,9,12 month time intervals
  • Time Frame: one year
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Utah

Overall Clinical Trial Officials and Contacts

John Fang, M.D. Study Director University of Utah HSC  

Information obtained from ClinicalTrials.gov on October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00204750

Study ID Number: 8953

ClinicalTrials.gov Identifier: NCT00204750

Health Authority: United States: Institutional Review Board