Study of Endoscopic Barrett's Esophagus Diagnosis - Full Text View

Sponsored by:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT00591461

Purpose

Barrett's esophagus (BE) is a condition that often occurs in patients who have had GERD for a long time. The researchers are interested in BE because it can sometimes become a cancer in the esophagus. The way that we currently diagnose BE is by performing an upper endoscopy and looking for a change in the color of the esophagus. This color change may represent BE. If the doctor sees this, he/she may take biopsies of this area.

Studies have shown that making the diagnosis of BE can be hard to make. One of the reasons why this may be is because doctors may interpret what they see differently during the procedure. In other words, they may see an esophagus that appears normal in color or abnormal in color.

The purpose of this study is to compare two doctors' impressions of the appearance of the esophagus during a single endoscopy procedure.

Condition
Barrett's Esophagus GERD

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, Prospective
Official Title:	A Prospective Study on the Interobserver Agreement of Endoscopic Barrett's Esophagus

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

The primary outcome will be the interobserver variability in the presence of columnar epithelium as well as the measured lengths. [ Time Frame: one endoscopy visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

frequency of pathology-confirmed BE [ Time Frame: one endoscopy visit ] [ Designated as safety issue: No ]
variables that predict endoscopic interobserver agreement and path-confirmation [ Time Frame: one endoscopy visit ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

Esophageal biopsies

Estimated Enrollment:	200
Study Start Date:	December 2007
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Study participants must be older than 18 years of age who are having an endoscopy performed to evaluate symptoms of GERD such as heartburn, acid taste in the mouth, dysphagia, dyspepsia, or those who are having a screening/surveillance exam for BE.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Study participants must be older than 18 years of age who are having an endoscopy performed to evaluate symptoms of GERD such as heartburn, acid taste in the mouth, dysphagia, dyspepsia, or those who are having a screening/surveillance exam for BE.

Criteria

Inclusion Criteria:

History of (h/o) GERD
Upper GI symptoms such as acid taste in mouth, dysphagia, dyspepsia
Screening or surveillance exam for BE

Exclusion Criteria:

Unable to consent
History of esophageal varices

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591461

Contacts

Contact: Amy Wang, MD	5034944373	wangamy@ohsu.edu
Contact: Katherine Hoda, MD	5034944373	hodak@ohsu.edu

Locations

United States, Oregon
OHSU	Recruiting
Portland, Oregon, United States, 97239
Sub-Investigator: Amy Wang, MD
PVAMC	Recruiting
Portland, Oregon, United States, 97239
Sub-Investigator: Amy Wang, MD

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:

Glenn M Eisen, MD, MPH

Oregon Health and Science University

More Information

Publications:

Eloubeidi MA, Provenzale D. Does this patient have Barrett's esophagus? The utility of predicting Barrett's esophagus at the index endoscopy. Am J Gastroenterol. 1999 Apr;94(4):937-43.

Padda S, Ramirez FC. Accuracy in the diagnosis of short-segment Barrett's esophagus: the role of endoscopic experience. Gastrointest Endosc. 2001 Nov;54(5):605-8.

Kim SL, Waring JP, Spechler SJ, Sampliner RE, Doos WG, Krol WF, Williford WO. Diagnostic inconsistencies in Barrett's esophagus. Department of Veterans Affairs Gastroesophageal Reflux Study Group. Gastroenterology. 1994 Oct;107(4):945-9.

Meining A, Ott R, Becker I, Hahn S, Mühlen J, Werner M, Höfler H, Classen M, Heldwein W, Rösch T. The Munich Barrett follow up study: suspicion of Barrett's oesophagus based on either endoscopy or histology only--what is the clinical significance? Gut. 2004 Oct;53(10):1402-7.

Guda NM, Partington S, Vakil N. Inter- and intra-observer variability in the measurement of length at endoscopy: Implications for the measurement of Barrett's esophagus. Gastrointest Endosc. 2004 May;59(6):655-8.

Responsible Party:	OHSU ( Glenn Eisen, MD MPH )
Study ID Numbers:	IRB00003558
Study First Received:	December 31, 2007
Last Updated:	January 10, 2008
ClinicalTrials.gov Identifier:	NCT00591461
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Barrett's Esophagus
Upper Endoscopy
Esophageal biopsies
Accuracy
Interobserver Agreement

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Abnormalities
Esophageal disorder
Gastrointestinal Diseases

Barrett Esophagus
Esophageal Diseases
Congenital Abnormalities

ClinicalTrials.gov processed this record on February 06, 2009