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

A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole of Symptomatic Lower Esophageal (Schatzki's) Rings

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00204750

Enrollment

Registered

2005-09-20

Start date

2001-08-31

Completion date

2006-12-31

Last updated

2008-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Lower Esophageal Ring

Keywords

lower esophageal ring, dysphagia, electrosurgical incision, bougie dilation, GERD

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).

Interventions

PROCEDUREBougie Dilation

Bougie dilation will be performed as standard

PROCEDURENeedle-knife incision

Needle-knife incision will be performed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Recurrence at one year of Schatzki's ring	One year

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026