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

Sponsor:	University of Utah
Collaborator:	PriCara, Unit of Ortho-McNeil, Inc.
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00204750

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 II Phase III

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:

MedlinePlus related topics: Esophagus Disorders Swallowing Disorders

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 February 09, 2012