Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs

Terminated

• Conditions: Fundic Gland Polyps

• Registration Number: NCT01130363
• Lead Sponsor: Columbia University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-05-24
• Study First Posted: 2010-05-26
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-29
• Last Update Posted: 2012-07-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 23

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States