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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-08-31

Study Completion Date

2006-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Lower Esophageal Ring Dysphagia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Bougie dilation

Group Type ACTIVE_COMPARATOR

Bougie Dilation

Intervention Type PROCEDURE

Bougie dilation will be performed as standard

2

Needle-knife incision

Group Type EXPERIMENTAL

Needle-knife incision

Intervention Type PROCEDURE

Needle-knife incision will be performed

Interventions

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Bougie Dilation

Bougie dilation will be performed as standard

Intervention Type PROCEDURE

Needle-knife incision

Needle-knife incision will be performed

Intervention Type PROCEDURE

Other Intervention Names

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Maloney dilation

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No