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Screening for Barrett's Esophagus in Otolaryngology Patients (SCE)

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ClinicalTrials.gov Identifier: NCT00695227
Recruitment Status : Unknown
Verified May 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Active, not recruiting
First Posted : June 11, 2008
Last Update Posted : May 3, 2011
Information provided by:

Study Description
Brief Summary:

The purpose of this project is to develop an accurate method to identify patients that suffer from acid reflux, but may not present with classic reflux symptoms (such as heart burn). Additionally, it is the purpose of this project to utilize the Unsedated Small-caliber Endoscopy (USE) to assess the prevalence of Barrett's esophagus in a population of patients with laryngopharyngeal reflux (LPR) symptoms and to define normal patterns of LPR. Laryngopharyngeal reflux (LPR) is when a small amount of stomach contents and acid are pushed up through the esophagus and may affect the vocal cords and upper respiratory tract.

It is suspected that patients with LPR symptoms may have a prevalence of Barrett's esophagus similar to that found in a population with typical reflux symptoms. We propose to systematically test this hypothesis using the USE.

This project is designed to improve the methods of identifying patients with a form of acid reflux that is often undetected, and thus untreated. If this project is successful then more patients with Barrett's esophagus will be identified; furthermore, screening and treatment for this pre-cancerous condition will be improved.

Condition or disease Intervention/treatment Phase
Extra Esophageal Symptoms: Cough Throat Clearing Hoarseness Difficulty Swallowing Drug: Proton Pump Inhibitor Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Screening for Barrett's Esophagus in Otolaryngology Patients
Study Start Date : May 2004
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012
Arms and Interventions

Intervention Details:
    Drug: Proton Pump Inhibitor
    Screened patients with extraesophageal reflux symptoms will be followed prospectively in order to gauge response to acid suppressing medication treatment. Non-responders will be tested with pharyngeal pH monitoring.

Outcome Measures

Primary Outcome Measures :
  1. The primary aim of the study is to establish that patients with symptoms of LPR who are referred to an otolaryngology clinic have a prevalence of Barrett's metaplasia equivalent to that of a population with GERD symptoms. [ Time Frame: One time ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Exclusion Criteria:

  • Prior anti-reflux surgery, laryngeal surgery, trauma to larynx Esophageal diverticulum Pregnancy Anticoagulation therapy Esophageal varices ENT malignancy History of recurrent epistaxis
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695227

United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Joshua Schindler, MD Oregon Health and Science University
More Information

Responsible Party: Joshua Schindler, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00695227     History of Changes
Other Study ID Numbers: K23 DK66165 (completed)
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
laryngopharyngeal reflux
extraesophageal reflux symptoms

Additional relevant MeSH terms:
Barrett Esophagus
Deglutition Disorders
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Pharyngeal Diseases
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action