Screening for Barrett's Esophagus in Otolaryngology Patients

NCT ID: NCT00695227

Last Updated: 2018-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Extraesophageal Symptoms Cough Throat Clearing Hoarseness Difficulty Swallowing

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Screening for Barrett's Esophagus

Group Type EXPERIMENTAL

Screening for Barrett's Esophagus

Intervention Type DIAGNOSTIC_TEST

Interventions

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Screening for Barrett's Esophagus

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Schindler, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status

Countries

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United States

References

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Nason KS, Murphy T, Schindler J, Schipper PH, Hoppo T, Diggs BS, Sauer DA, Shaheen NJ, Morris CD, Jobe BA; Barrett's Esophagus Risk Consortium (BERC). A cross-sectional analysis of the prevalence of Barrett esophagus in otolaryngology patients with laryngeal symptoms. J Clin Gastroenterol. 2013 Oct;47(9):762-8. doi: 10.1097/MCG.0b013e318293d522.

Reference Type RESULT
PMID: 23751847 (View on PubMed)

Other Identifiers

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K23DK066165

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K23 DK66165 (completed)

Identifier Type: -

Identifier Source: org_study_id

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