NCT00591461

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2007

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 11, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

December 11, 2019

Status Verified

December 1, 2019

Enrollment Period

2.2 years

First QC Date

December 31, 2007

Last Update Submit

December 9, 2019

Conditions

Barrett's EsophagusGERD

Keywords

Barrett's EsophagusUpper EndoscopyEsophageal biopsiesAccuracyInterobserver Agreement

Outcome Measures

Primary Outcomes (1)

  • The primary outcome will be the interobserver variability in the presence of columnar epithelium as well as the measured lengths.

    one endoscopy visit

Secondary Outcomes (2)

  • frequency of pathology-confirmed BE

    one endoscopy visit

  • variables that predict endoscopic interobserver agreement and path-confirmation

    one endoscopy visit

Study Arms (1)

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 Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Unable to consent
  • History of esophageal varices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

OHSU

Portland, Oregon, 97239, United States

Location

PVAMC

Portland, Oregon, 97239, United States

Location

Related 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. doi: 10.1111/j.1572-0241.1999.990_m.x.

    PMID: 10201460BACKGROUND

  • 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.

    PMID: 11677477BACKGROUND

  • 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.

    PMID: 7926484BACKGROUND

  • 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.

    PMID: 15361485BACKGROUND

  • 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.

    PMID: 15114308BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Esophageal biopsies

MeSH Terms

Conditions

Barrett EsophagusGastroesophageal Reflux

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesEsophageal Motility DisordersDeglutition Disorders

Study Officials

  • Glenn M Eisen, MD, MPH

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 11, 2008

Study Start

December 1, 2007

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

December 11, 2019

Record last verified: 2019-12

Locations

US(2)