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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00695227
First received: June 6, 2008
Last updated: May 2, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Extra Esophageal Symptoms:
Cough
Throat Clearing
Hoarseness
Difficulty Swallowing
Drug: Proton Pump Inhibitor
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Screening for Barrett's Esophagus in Otolaryngology Patients

Resource links provided by NLM:


Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: May 2004
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695227

Locations
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239-3098
Sponsors and Collaborators
Investigators
Principal Investigator: Joshua Schindler, MD Oregon Health and Science University
  More Information

No publications provided

Responsible Party: Joshua Schindler, Oregon Health & Science University
ClinicalTrials.gov Identifier: NCT00695227     History of Changes
Other Study ID Numbers: K23 DK66165 (completed), DK066165-02
Study First Received: June 6, 2008
Last Updated: May 2, 2011
Health Authority: United States: Food and Drug Administration
United States: Federal Government

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
Hoarseness
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014