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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00695227
Recruitment Status : Completed
First Posted : June 11, 2008
Last Update Posted : March 6, 2018
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Tracking Information
First Submitted Date  ICMJE June 6, 2008
First Posted Date  ICMJE June 11, 2008
Last Update Posted Date March 6, 2018
Actual Study Start Date  ICMJE May 2004
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Screening for Barrett's Esophagus in Otolaryngology Patients
Official Title  ICMJE Screening for Barrett's Esophagus in Otolaryngology Patients
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Extraesophageal Symptoms
  • Cough
  • Throat Clearing
  • Hoarseness
  • Difficulty Swallowing
Intervention  ICMJE Diagnostic Test: Screening for Barrett's Esophagus
Study Arms  ICMJE Experimental: Screening for Barrett's Esophagus
Intervention: Diagnostic Test: Screening for Barrett's Esophagus
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 2, 2018)
295
Original Estimated Enrollment  ICMJE
 (submitted: June 9, 2008)
500
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00695227
Other Study ID Numbers  ICMJE K23 DK66165 (completed)
K23DK066165 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Sponsor  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators  ICMJE Oregon Health and Science University
Investigators  ICMJE
Principal Investigator: Joshua Schindler, MD Oregon Health and Science University
PRS Account National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP