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

Phase 3CompletedNCT00204750

University of Utah50 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lower Esophageal Ring Dysphagia

Interventions

Bougie DilationPROCEDURE

Bougie dilation will be performed as standard

Needle-knife incisionPROCEDURE

Needle-knife incision will be performed

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University of Utah HSC

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Recurrence at one year of Schatzki's ring

Time frame: One year

Secondary Outcomes

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

Data from ClinicalTrials.gov

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