EsophagitisNCT00256529
Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
An observational study of Esophagitis, run by University of Utah at 1 site in United States.
Trial summary
This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Esophagitis
- What is being tested?
- EGD with biopsies
- Type of treatment
- Surgery or procedure
- How many people
- 483 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2005to Feb 2012
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients presenting with dysphagia will be eligibile for enrollment into the study.
Who may be able to join
- Patients aged 18-90 presenting with dysphagia or food impaction
- Ability to undergo esophagogastroduodenoscopy and biopsies
- No significant cardiopulmonary disease, or other contraindication to EGD
Who cannot join
- Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR
- Inability to provide informed consent
- Esophageal varices
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Veterans Affairs
Salt Lake City, Utah, 84148
About this study
This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. We hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with EE.
Read the detailed description
All patients presenting with dysphagia who do not already carry a previous diagnosis for their dysphagia will be asked to enroll. If patients have undergone previous work up for dysphagia such as manometry, 24-hour probe, or barium swallow they can still participate in this study. Informed consent will take place prior to enrollment. After patients present with dysphagia they will fill-out a questionnaire regarding their dysphagia symptoms. An EGD with biopsies will then be performed. Biopsies will be taken from 4 quadrants in the proximal and distal esophagus. The distal esophagus biopsies will be taken 5 cm proximal to the Z-line. Proximal biopsies will be taken anywhere proximal to 30 cm from the incisors.
- Conditions
- Esophagitis
- Being tested
- EGD with biopsies
- Keywords
- dysphagia, eosinophilic esophagitis
- Medical subject headings
- Esophagitis, Deglutition Disorders, Eosinophilic Esophagitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EGD with biopsiesProcedure or surgery
Also called Upper endoscopy
All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.
| Study group | Role | What they receive |
|---|---|---|
| I | All subjects presenting in with dysphagia will be in this cohort. Receives: Procedure: EGD with biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the percentage of patients who present with dysphagia who have EE by histologic criteria
Measured: December 2010
Secondary outcomes (3)
To assess the demographics of the EE patients with dysphagia
Measured: December 2010
To measure the frequency, severity, and time course of dysphagia in patients with EE
Measured: December 2010
To assess percentage of EE patients with recurrent, versus acute dysphagia
Measured: December 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionJul 2011
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EsophagitisStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Time perspective
- Prospective
- Enrolment
- 483 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn A. Peterson, University of Utah
- Investigators
- Kathryn Byrne, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256529
- Sponsor's protocol ID
- 14543
- Status last verified
- Dec 2014
- First submitted
- 17 Nov 2005
- Last updated
- 15 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
- ClinicalTrials.gov ID
- NCT00256529
- Acronym / sponsor ID
- 14543
- Conditions
- Esophagitis
- Keywords
- dysphagia, eosinophilic esophagitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 483 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Jul 2011 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 21 Nov 2005 (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.
This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EoE) and to establish which presenting factors warrant esophageal biopsies. We hypothesize that a greater than expected percentage of patients who are biopsies will have histologic changes consistent with EE.
Detailed description
All patients presenting with dysphagia who do not already carry a previous diagnosis for their dysphagia will be asked to enroll. If patients have undergone previous work up for dysphagia such as manometry, 24-hour probe, or barium swallow they can still participate in this study. Informed consent will take place prior to enrollment. After patients present with dysphagia they will fill-out a questionnaire regarding their dysphagia symptoms. An EGD with biopsies will then be performed. Biopsies will be taken from 4 quadrants in the proximal and distal esophagus. The distal esophagus biopsies will be taken 5 cm proximal to the Z-line. Proximal biopsies will be taken anywhere proximal to 30 cm from the incisors.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| I | – | Procedure: EGD with biopsiesAll subjects presenting in with dysphagia will be in this cohort. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with dysphagia will be eligibile for enrollment into the study.
Key inclusion criteria (3 listed)
- Patients aged 18-90 presenting with dysphagia or food impaction
- Ability to undergo esophagogastroduodenoscopy and biopsies
- No significant cardiopulmonary disease, or other contraindication to EGD
Key exclusion criteria (3 listed)
- Contradiction to EGD and/or biopsies such as Boerhaave's syndrome, or history or bleeding disorder or elevated INR
- Inability to provide informed consent
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EGD with biopsiesAlso: Upper endoscopyAll subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus. | Procedure or surgery | I |
Primary outcome
To assess the percentage of patients who present with dysphagia who have EE by histologic criteria
Time frame: December 2010
3 secondary outcomes
To assess the demographics of the EE patients with dysphagia
Time frame: December 2010
To measure the frequency, severity, and time course of dysphagia in patients with EE
Time frame: December 2010
To assess percentage of EE patients with recurrent, versus acute dysphagia
Time frame: December 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2014.
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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.
Kathryn Byrne, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagitis, run by University of Utah at 1 site 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 3 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: finished, as of the sponsor's last update on 15 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To assess the percentage of patients who present with dysphagia who have EE by histologic criteria (time frame: December 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2014.