Screening for Barrett's Esophagus in Otolaryngology Patients (SCE)
Primary Purpose
Extraesophageal Symptoms, Cough, Throat Clearing
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening for Barrett's Esophagus
Sponsored by
About this trial
This is an interventional diagnostic trial for Extraesophageal Symptoms focused on measuring laryngopharyngeal reflux, extraesophageal reflux symptoms
Eligibility 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
Sites / Locations
- Oregon Health & Science University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Screening for Barrett's Esophagus
Arm Description
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00695227
First Posted
June 6, 2008
Last Updated
March 2, 2018
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Oregon Health and Science University
1. Study Identification
Unique Protocol Identification Number
NCT00695227
Brief Title
Screening for Barrett's Esophagus in Otolaryngology Patients
Acronym
SCE
Official Title
Screening for Barrett's Esophagus in Otolaryngology Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
May 2004 (Actual)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
Oregon Health and Science University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extraesophageal Symptoms, Cough, Throat Clearing, Hoarseness, Difficulty Swallowing
Keywords
laryngopharyngeal reflux, extraesophageal reflux symptoms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
295 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Screening for Barrett's Esophagus
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Screening for Barrett's Esophagus
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joshua Schindler, MD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23751847
Citation
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.
Results Reference
result
Learn more about this trial
Screening for Barrett's Esophagus in Otolaryngology Patients
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