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

Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00204750
• Other study ID #: 8953
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 12, 2005
• Last updated: December 23, 2007
• Start date: August 2001
• Est. completion date: December 2006

Study information

• Verified date: December 2007
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Lower Esophageal Ring

Intervention

Procedure:
• Bougie Dilation
Bougie dilation will be performed as standard
• Needle-knife incision
Needle-knife incision will be performed

Locations

Country	Name	City	State
United States	University of Utah HSC	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	PriCara, Unit of Ortho-McNeil, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence at one year of Schatzki's ring		One year	No
Secondary	GERD score at 1,3,6,9,12 month time intervals		one year	No
Secondary	Dysphagia score at 1,3,6,9,12 month time intervals		one year	No