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

Phase 2

Completed

• Conditions: Lower Esophageal Ring; Dysphagia
• Interventions: Procedure: Bougie Dilation; Procedure: Needle-knife incision

• Registration Number: NCT00204750
• Lead Sponsor: University of Utah

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 Timeline

• Study Start: 2001-08
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-23
• Last Update Posted: 2008-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Bougie Dilation	Bougie dilation
2	Needle-knife incision	Needle-knife incision

Primary Outcome Measures

Name	Time	Method
Recurrence at one year of Schatzki's ring	One year

Secondary Outcome Measures

Name	Time	Method
GERD score at 1,3,6,9,12 month time intervals	one year
Dysphagia score at 1,3,6,9,12 month time intervals	one year

Trial Locations

Locations (1)

University of Utah HSC; 🇺🇸 Salt Lake City, Utah, United States