Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2001
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedJanuary 4, 2008
December 1, 2007
5.3 years
September 12, 2005
December 23, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence at one year of Schatzki's ring
One year
Secondary Outcomes (2)
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
Study Arms (2)
1
ACTIVE COMPARATORBougie dilation
2
EXPERIMENTALNeedle-knife incision
Interventions
Bougie dilation will be performed as standard
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Utahlead
- PriCara, Unit of Ortho-McNeil, Inc.collaborator
Study Sites (1)
University of Utah HSC
Salt Lake City, Utah, 84132, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John Fang, M.D.
University of Utah HSC
- PRINCIPAL INVESTIGATOR
James A DiSario, M.D.
University of Utah HSC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
August 1, 2001
Primary Completion
December 1, 2006
Study Completion
December 1, 2006
Last Updated
January 4, 2008
Record last verified: 2007-12