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

This study has been completed.
Sponsor:
Collaborator:
PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00204750
First received: September 12, 2005
Last updated: December 23, 2007
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Lower Esophageal Ring
Dysphagia
 Procedure: Bougie Dilation
Procedure: Needle-knife incision
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Recurrence at one year of Schatzki's ring [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GERD score at 1,3,6,9,12 month time intervals [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Dysphagia score at 1,3,6,9,12 month time intervals [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 50
Study Start Date: August 2001
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Bougie dilation
 Procedure: Bougie Dilation
Bougie dilation will be performed as standard
Other Name: Maloney dilation
Experimental: 2
Needle-knife incision
 Procedure: Needle-knife incision
Needle-knife incision will be performed

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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00204750

Locations
United States, Utah
University of Utah HSC
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
PriCara, Unit of Ortho-McNeil, Inc.
Investigators
Study Director: John Fang, M.D. University of Utah HSC
Principal Investigator: James A DiSario, M.D. University of Utah HSC
  More Information

No publications provided

Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00204750     History of Changes
Other Study ID Numbers: 8953
Study First Received: September 12, 2005
Last Updated: December 23, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
lower esophageal ring
dysphagia
electrosurgical incision
bougie dilation
GERD

Additional relevant MeSH terms:
Deglutition Disorders
Dilatation, Pathologic
Esophageal Diseases
Gastrointestinal Diseases
 Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013