Clinical trial NCT00591461: Study of Endoscopic Barrett's Esophagus Diagnosis
Official title: A Prospective Study on the Interobserver Agreement of Endoscopic Barrett's Esophagus
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Barrett's Esophagus
GERD
Keywords: Barrett's Esophagus
Upper Endoscopy
Esophageal biopsies
Accuracy
Interobserver Agreement
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility 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

Primary outcomes:
measure: The primary outcome will be the interobserver variability in the presence of columnar epithelium as well as the measured lengths.
timeFrame: one endoscopy visit
Secondary outcomes:
measure: frequency of pathology-confirmed BE
timeFrame: one endoscopy visit
measure: variables that predict endoscopic interobserver agreement and path-confirmation
timeFrame: one endoscopy visit
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU
state: Oregon
city: Portland
country: United States
facility: PVAMC
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Glenn M Eisen, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1111/j.1572-0241.1999.990_m.x.
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. doi: 10.1067/mge.2001.118714.
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.
citation: Meining A, Ott R, Becker I, Hahn S, Muhlen J, Werner M, Hofler H, Classen M, Heldwein W, Rosch 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. doi: 10.1136/gut.2003.036822.
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. doi: 10.1016/s0016-5107(04)00182-8.