Screening for Barrett's Esophagus in Otolaryngology Patients

Cough Clinical Trial

— SCE  

Official title:

Screening for Barrett's Esophagus in Otolaryngology Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00695227
• Other study ID #: K23 DK66165 (completed)
• Secondary ID: K23DK066165
• Status: Completed
• Phase: N/A
• First received: June 6, 2008
• Last updated: March 2, 2018
• Start date: May 2004
• Est. completion date: December 2011

Study information

• Verified date: March 2018
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 295
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Cough
• Deglutition Disorders
• Difficulty Swallowing
• Extraesophageal Symptoms
• Hoarseness
• Throat Clearing

Intervention

Diagnostic Test:
• Screening for Barrett's Esophagus

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & 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 laryng — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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