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

December 23, 2007 updated by: University of Utah

A Randomized, Prospective Trial of Electrosurgical Incision Followed by Rabeprazole Versus Bougie Dilation Followed by Rabeprazole 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah HSC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Bougie dilation
Procedure: Bougie Dilation
Bougie dilation will be performed as standard
Other Names:
  • Maloney dilation
EXPERIMENTAL: 2
Needle-knife incision
Procedure: Needle-knife incision
Needle-knife incision will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence at one year of Schatzki's ring
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
GERD score at 1,3,6,9,12 month time intervals
Time Frame: one year
one year
Dysphagia score at 1,3,6,9,12 month time intervals
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Collaborators

PriCara, Unit of Ortho-McNeil, Inc.

Investigators

  • Study Director: John Fang, M.D., University of Utah HSC
  • Principal Investigator: James A DiSario, M.D., University of Utah HSC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2001

Primary Completion (ACTUAL)

December 1, 2006

Study Completion (ACTUAL)

December 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

January 4, 2008

Last Update Submitted That Met QC Criteria

December 23, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8953

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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