Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01130363

Enrollment

Registered

2010-05-26

Start date

2006-10-31

Completion date

2012-04-30

Last updated

2012-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fundic Gland Polyps

Keywords

Proton Pump Inhibitor, Gastric carcinoid tumors, Gastric cancer, Fundic Gland Polyps

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Yes

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Number of patients with fundic gland polyps and PPI use that have a higher gastric pH	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.

Countries

United States

Outcome results