Barrett's EsophagusNCT00591461
Study of Endoscopic Barrett's Esophagus Diagnosis
An observational study of Barrett's Esophagus and GERD, run by Oregon Health and Science University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Barrett's Esophagus, GERD
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2007to Mar 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- History of (h/o) GERD
- Upper GI symptoms such as acid taste in mouth, dysphagia, dyspepsia
- Screening or surveillance exam for BE
Who cannot join
- Unable to consent
- History of esophageal varices
Trial locations and contacts
2 sites in 1 country.
United States2 sites
OHSU
Portland, Oregon, 97239
PVAMC
Portland, Oregon, 97239
About this study
Official title: A Prospective Study on the Interobserver Agreement of Endoscopic Barrett's Esophagus
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.
- Conditions
- Barrett's Esophagus, GERD
- Keywords
- Barrett's Esophagus, Upper Endoscopy, Esophageal biopsies, Accuracy, Interobserver Agreement
- Medical subject headings
- Barrett Esophagus, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the interobserver variability in the presence of columnar epithelium as well as the measured lengths.
Measured: one endoscopy visit
Secondary outcomes (2)
frequency of pathology-confirmed BE
Measured: one endoscopy visit
variables that predict endoscopic interobserver agreement and path-confirmation
Measured: one endoscopy visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Lack of recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Barrett's EsophagusStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn M Eisen, MD, MPH, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00591461
- Sponsor's protocol ID
- IRB00003558
- Status last verified
- Dec 2019
- First submitted
- 31 Dec 2007
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1111/j.1572-0241.1999.990_m.x.
PubMed 10201460Padda 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.
PubMed 11677477Kim 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.
PubMed 7926484Meining 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.
PubMed 15361485Guda 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.
PubMed 15114308
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Interobserver Agreement of Endoscopic Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT00591461
- Acronym / sponsor ID
- IRB00003558
- Conditions
- Barrett's Esophagus, GERD
- Keywords
- Barrett's Esophagus, Upper Endoscopy, Esophageal biopsies, Accuracy, Interobserver Agreement
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of recruitment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- History of (h/o) GERD
- Upper GI symptoms such as acid taste in mouth, dysphagia, dyspepsia
- Screening or surveillance exam for BE
Key exclusion criteria (2 listed)
- Unable to consent
- History of esophageal varices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
frequency of pathology-confirmed BE
Time frame: one endoscopy visit
variables that predict endoscopic interobserver agreement and path-confirmation
Time frame: one endoscopy visit
Results and safety
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2019.
- Background: PubMed 10201460Eloubeidi 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.
- Background: PubMed 11677477Padda 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.
- Background: PubMed 7926484Kim 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.
- Background: PubMed 15361485Meining 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.
- Background: PubMed 15114308Guda 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glenn M Eisen, MD, MPH principal investigator
Oregon Health and Science University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Barrett's Esophagus and GERD, run by Oregon Health and Science University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00591461, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2019.