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临床试验/NCT01404832
NCT01404832终止4 期

The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors

Dallas VA Medical Center2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2007年10月最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
102
试验地点
2
主要终点
Number of Participants With Eosinophilic Esophagitis

研究概览

简要总结

Background: Up to 40% of patients who are treated with PPIs for symptoms that are thought to be due to GERD experience only incomplete relief of their symptoms. Those patients are deemed "PPI failures." Esophageal pH monitoring studies have shown that PPI failure rarely is due to persistent acid reflux. Recently, heartburn that is refractory to treatment with PPIs has been described in patients with eosinophilic esophagitis, a disorder of unknown etiology in which eosinophils infiltrate the squamous epithelium of the esophagus, where they cause symptoms and tissue injury. Presently, it is not clear how often eosinophilic esophagitis underlies PPI failure for patients with GERD symptoms.

Purpose: To estimate the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD.

Methods: Patients referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy will be invited to participate in the study. Patients who provide informed consent will have a medical history taken. Women of child bearing potential will have a pregnancy test. The patients' current PPI therapy will be discontinued, and patients will be treated with lansoprazole 30 mg BID for one week. The patient will return to the clinic one week later. Patients who feel that their heartburn has not improved by more than 50% from baseline will have an endoscopic evaluation. During the endoscopic examination, biopsy specimens will be taken as follows: A. Two specimens from the proximal esophagus at 20 cm from the incisor teeth. B. Two specimens from the mid-esophagus at 28 cm from the incisor teeth. C. Two specimens from the distal esophagus, 3 cm above the squamo-columnar junction. D. Two specimens from the distal esophagus, 1 cm above the squamo-columnar junction. E. Two specimens from the second portion of the duodenum (to see if the eosinophilia is confined to the esophagus, or part of a more extensive eosinophilic gastroenteritis). A diagnosis of eosinophilic esophagitis will be made if there is at least one high-power field with >25 eosinophils, or two or more high-power fields with >15 eosinophils.

Potential Benefits: This study will provide an estimate on the frequency with which eosinophilic esophagitis is the cause of "PPI failure" in patients thought to have heartburn due to GERD. This has substantial potential importance for patient management.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Male and female patients ages 18 years and older who are referred to the Division of Gastroenterology at the Dallas VA Medical Center for the evaluation of heartburn that is refractory to PPI therapy

排除标准

  • Patients unwilling or unable to provide informed consent.
  • Allergy to lansoprazole.
  • Patients taking warfarin.
  • Coagulopathy that precludes safe biopsy of the esophagus.
  • Comorbidity that precludes safe participation in the study.

结局指标

主要结局

Number of Participants With Eosinophilic Esophagitis

时间窗: 8 weeks

次要结局

  • Number of Patients Who Had Resolution of Heartburn With Lansoprazole(After 8 weeks of treatment)

研究者

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

Stuart Spechler

PI

Dallas VA Medical Center

研究点 (2)

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