Study of Endoscopic Barrett's Esophagus Diagnosis

GERD Clinical Trial

Official title:

A Prospective Study on the Interobserver Agreement of Endoscopic Barrett's Esophagus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00591461
• Other study ID #: IRB00003558
• Status: Terminated
• Start date: December 2007
• Est. completion date: March 2010

Study information

• Verified date: December 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• GERD

Locations

Country	Name	City	State
United States	OHSU	Portland	Oregon
United States	PVAMC	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome will be the interobserver variability in the presence of columnar epithelium as well as the measured lengths.		one endoscopy visit
Secondary	frequency of pathology-confirmed BE		one endoscopy visit
Secondary	variables that predict endoscopic interobserver agreement and path-confirmation		one endoscopy visit