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临床试验/NCT00256529
NCT00256529已完成不适用

Prospective Analysis of Eosinophilic Esophagitis in Patients Presenting With Dysphagia

University of Utah1 个研究点 分布在 1 个国家目标入组 483 人开始时间: 2005年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
483
试验地点
1
主要终点
To assess the percentage of patients who present with dysphagia who have EE by histologic criteria

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

To assess the percentage of patients who present with dysphagia who have EE by histologic criteria

时间窗: December 2010

次要结局

  • To assess the demographics of the EE patients with dysphagia(December 2010)
  • To assess percentage of EE patients with recurrent, versus acute dysphagia(December 2010)
  • To measure the frequency, severity, and time course of dysphagia in patients with EE(December 2010)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kathryn A. Peterson

MD

University of Utah

研究点 (1)

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