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Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings

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ClinicalTrials.gov Identifier: NCT00204750
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : January 4, 2008
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
University of Utah

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date January 4, 2008
Study Start Date  ICMJE August 2001
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 23, 2007)
Recurrence at one year of Schatzki's ring [ Time Frame: One year ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Recurrence at one year of schatki's ring
  • Dysphagia score at 1,3,6,9,12 month time intervals
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 23, 2007)
  • GERD score at 1,3,6,9,12 month time intervals [ Time Frame: one year ]
  • Dysphagia score at 1,3,6,9,12 month time intervals [ Time Frame: one year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
GERD score at 1,3,6,9,12 month time intervals
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of Electrosurgical Incision Versus Bougie Dilation of Symptomatic Lower Esophageal (Schatzki's) Rings
Official Title  ICMJE A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lower Esophageal Ring
  • Dysphagia
Intervention  ICMJE
  • Procedure: Bougie Dilation
    Bougie dilation will be performed as standard
    Other Name: Maloney dilation
  • Procedure: Needle-knife incision
    Needle-knife incision will be performed
Study Arms  ICMJE
  • Active Comparator: 1
    Bougie dilation
    Intervention: Procedure: Bougie Dilation
  • Experimental: 2
    Needle-knife incision
    Intervention: Procedure: Needle-knife incision
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
50
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2006
Actual Primary Completion Date December 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00204750
Other Study ID Numbers  ICMJE 8953
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE PriCara, Unit of Ortho-McNeil, Inc.
Investigators  ICMJE
Study Director: John Fang, M.D. University of Utah HSC
Principal Investigator: James A DiSario, M.D. University of Utah HSC
PRS Account University of Utah
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP