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Sponsored by: |
University of Utah |
Information provided by: | University of Utah |
ClinicalTrials.gov Identifier: | NCT00256529 |
This is a prospective descriptive cross sectional study to determine the percentage of patients presenting with dysphagia who are found to have eosinophilic esophagitis (EE) 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.
Condition | Intervention |
Esophagitis |
Procedure: EGD with biopsies |
MedlinePlus related topics: | Swallowing Disorders |
Study Type: | Observational |
Study Design: | Other, Prospective |
Official Title: | Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia |
4 quadrant distal and proximal biopsies of the esophagus
Estimated Enrollment: | 500 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
I
All subjects presenting in with dysphagia will be in this cohort.
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Procedure: EGD with biopsies
All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.
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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.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All patients presenting with dysphagia will be eligibile for enrollment into the study.
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathryn Byrne, M.D. | 801-581-7802 | kathryn.byrne@hsc.utah.edu |
Contact: Kristen Thomas, BS | 801-587-9854 | kristen.thomas@hsc.utah.edu |
United States, Utah | |||||
Department of Veterans Affairs | Recruiting | ||||
Salt Lake City, Utah, United States, 84148 | |||||
Contact: Mae Go, M.D. 801-584-1231 mae.go@hsc.utah.edu | |||||
Sub-Investigator: Mae Go, M.D. |
University of Utah |
Principal Investigator: | Kathryn Byrne, M.D. | University of Utah |
Responsible Party: | University of Utah ( Kathryn Byrne, M.D. ) |
Study ID Numbers: | 14543 |
First Received: | November 17, 2005 |
Last Updated: | May 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00256529 |
Health Authority: | United States: Institutional Review Board |
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