Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00256529
Recruitment Status : Completed
First Posted : November 21, 2005
Last Update Posted : December 15, 2014
Sponsor:
Information provided by (Responsible Party):
Kathryn A. Peterson, University of Utah

Tracking Information
First Submitted Date November 17, 2005
First Posted Date November 21, 2005
Last Update Posted Date December 15, 2014
Study Start Date November 2005
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2008)
To assess the percentage of patients who present with dysphagia who have EE by histologic criteria [ Time Frame: December 2010 ]
Original Primary Outcome Measures
 (submitted: November 17, 2005)
To assess the percentage of patients who present with dysphagia who have EE by histologic criteria
Change History Complete list of historical versions of study NCT00256529 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 5, 2008)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: November 17, 2005)
  • To assess the demographics of the EE patients with dysphagia
  • To measure the frequency, severity, and time course of dysphagia in patients with EE
  • To assess percentage of EE patients with recurrent, versus acute dysphagia
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Official Title Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia
Brief 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. 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 Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
4 quadrant distal and proximal biopsies of the esophagus
Sampling Method Non-Probability Sample
Study Population All patients presenting with dysphagia will be eligibile for enrollment into the study.
Condition Esophagitis
Intervention Procedure: EGD with biopsies
All subjects presenting with dysphagia will undergo an EGD with distal and proximal biopsies of the esophagus.
Other Name: Upper endoscopy
Study Groups/Cohorts I
All subjects presenting in with dysphagia will be in this cohort.
Intervention: Procedure: EGD with biopsies
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 2, 2011)
483
Original Enrollment
 (submitted: November 17, 2005)
60
Actual Study Completion Date February 2012
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00256529
Other Study ID Numbers 14543
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Kathryn A. Peterson, University of Utah
Study Sponsor University of Utah
Collaborators Not Provided
Investigators
Principal Investigator: Kathryn Byrne, M.D. University of Utah
PRS Account University of Utah
Verification Date December 2014