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

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ClinicalTrials.gov Identifier: NCT00695227
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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
Extraesophageal Symptoms Cough Throat Clearing Hoarseness Difficulty Swallowing Diagnostic Test: Screening for Barrett's Esophagus Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 295 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Screening for Barrett's Esophagus in Otolaryngology Patients
Actual Study Start Date : May 2004
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Arm Intervention/treatment
Experimental: Screening for Barrett's Esophagus Diagnostic Test: Screening for Barrett's Esophagus



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 ]


Information from the National Library of Medicine

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

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

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


Locations
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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)
Oregon Health and Science University
Investigators
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Principal Investigator: Joshua Schindler, MD Oregon Health and Science University
Publications of Results:
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Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00695227    
Other Study ID Numbers: K23 DK66165 (completed)
K23DK066165 ( U.S. NIH Grant/Contract )
First Posted: June 11, 2008    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: March 2018
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
laryngopharyngeal reflux
extraesophageal reflux symptoms
Additional relevant MeSH terms:
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Barrett Esophagus
Deglutition Disorders
Hoarseness
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System 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