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临床试验/NCT01130363
NCT01130363终止不适用

Determination of a Possible Association of Fundic Gland Polyps With the Use of Proton Pump Inhibitor Drugs

Columbia University1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2006年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
23
试验地点
1
主要终点
Number of patients with fundic gland polyps and PPI use that have a higher gastric pH

研究概览

简要总结

The class of proton pump inhibitor (PPI) medications such as omeprazole has proven extremely effective in the treatment and prevention of gastric and duodenal ulcers. Although the FDA approval for PPI therapy is limited to 6-8 weeks, many individuals remain on these agents for years, and human studies have suggested that long-term use of a PPI can result in enterochromaffin-like (ECL) cell hyperplasia, as well as being associated with the development of fundic-gland polyps of the stomach. These findings raise the concern of the possibility that long-term use of PPIs may predispose to the development of neuroendocrine tumors in patients. The investigators aim to examine clinical parameters, including history of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. The investigators hypothesize that there is a correlation between fundic gland polyps of the stomach and the use of proton pump inhibiter medications.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 and above.
  • Able and willing to sign informed consent.
  • The patient had a gastric fundic gland polyp detected on EGD that was removed and sent to pathology or patient had no fundic gland polyps on EGD but are on PPIs and will serve as controls.

排除标准

  • Unwilling or unable to sign informed consent for the study.

结局指标

主要结局

Number of patients with fundic gland polyps and PPI use that have a higher gastric pH

时间窗: Up to 1 year

We aim to examine clinical parameters, including history of PPI use and fasting gastrin levels, as well as histologic characteristics (particularly the presence of ECL-cell hyperplasia) of patients found to have fundic gland polyps during endoscopy. We believe there is a correlation between fundic gland polyps of the stomach and use of proton pump inhibiter medications.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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