Screening for Barrett's Esophagus in Otolaryngology Patients

NCT00695227 | Completed DMC

• 2 other identifiers: K23 DK66165 (completed)K23DK066165
• Study Type: interventional
• Target: 295
• Locations: 1 country
• Sites: 1

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.

Conditions

Extraesophageal Symptoms; Cough; Throat Clearing; Hoarseness; Difficulty Swallowing

Keywords

laryngopharyngeal reflux; extraesophageal reflux symptoms

Outcome Measures

Primary Outcomes (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.

  One time

Study Arms (1)

Screening for Barrett's Esophagus

EXPERIMENTAL

Diagnostic Test: Screening for Barrett's Esophagus

Interventions

Screening for Barrett's Esophagus DIAGNOSTIC_TEST

Screening for Barrett's Esophagus

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead
• Oregon Health and Science University: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239-3098, United States

Location

Related Publications (1)

• 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.

  PMID: 23751847 RESULT

MeSH Terms

Conditions

Cough; Hoarseness; Deglutition Disorders; Laryngopharyngeal Reflux

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Voice Disorders; Laryngeal Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Gastroesophageal Reflux; Esophageal Motility Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Study Officials

• Joshua Schindler, MD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 11, 2008
• Study Start: May 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 6, 2018

Record last verified: 2018-03

Locations

US (1)