Back to resultsTrial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
Primary Purpose
Lower Esophageal Ring, Dysphagia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bougie Dilation
Needle-knife incision
Sponsored by
About this trial
This is an interventional treatment trial for Lower Esophageal Ring focused on measuring lower esophageal ring, dysphagia, electrosurgical incision, bougie dilation, GERD
Eligibility Criteria
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
Sites / Locations
- University of Utah HSC
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Bougie dilation
Needle-knife incision
Outcomes
Primary Outcome Measures
Recurrence at one year of Schatzki's ring
Secondary Outcome Measures
GERD score at 1,3,6,9,12 month time intervals
Dysphagia score at 1,3,6,9,12 month time intervals
Full Information
NCT ID
NCT00204750
First Posted
September 12, 2005
Last Updated
December 23, 2007
Sponsor
University of Utah
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00204750
Brief Title
Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
August 2001 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Utah
Collaborators
PriCara, Unit of Ortho-McNeil, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lower Esophageal Ring, Dysphagia
Keywords
lower esophageal ring, dysphagia, electrosurgical incision, bougie dilation, GERD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Bougie dilation
Arm Title
2
Arm Type
Experimental
Arm Description
Needle-knife incision
Intervention Type
Procedure
Intervention Name(s)
Bougie Dilation
Other Intervention Name(s)
Maloney dilation
Intervention Description
Bougie dilation will be performed as standard
Intervention Type
Procedure
Intervention Name(s)
Needle-knife incision
Intervention Description
Needle-knife incision will be performed
Primary Outcome Measure Information:
Title
Recurrence at one year of Schatzki's ring
Time Frame
One year
Secondary Outcome Measure Information:
Title
GERD score at 1,3,6,9,12 month time intervals
Time Frame
one year
Title
Dysphagia score at 1,3,6,9,12 month time intervals
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Fang, M.D.
Organizational Affiliation
University of Utah HSC
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
James A DiSario, M.D.
Organizational Affiliation
University of Utah HSC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Utah HSC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
We'll reach out to this number within 24 hrs