Skip to main content
OpenTrials
Completed

NCT Number: NCT00204750

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Utah HSC

Salt Lake City, Utah, 84132, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bougie Dilation

Procedure

Bougie dilation will be performed as standard

Other names: Maloney dilation

Needle-knife incision

Procedure

Needle-knife incision will be performed

Primary outcomes

  1. Recurrence at one year of Schatzki's ring

    Time frame: One year

Secondary outcomes

  1. GERD score at 1,3,6,9,12 month time intervals

    Time frame: one year

  2. Dysphagia score at 1,3,6,9,12 month time intervals

    Time frame: one year

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • PriCara, Unit of Ortho-McNeil, Inc.

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Jan 4, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.