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Clinical Trials/NCT00695227
NCT00695227
Completed
Not Applicable

Screening for Barrett's Esophagus in Otolaryngology Patients

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)1 site in 1 country295 target enrollmentMay 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Extraesophageal Symptoms
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Enrollment
295
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2004
End Date
December 2011
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Study Sites (1)

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