Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs
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.
Fundic Gland Polyps
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Determination of a Possible Association of Fundic Gland Polyps With the Use of Proton Pump Inhibitor Drugs|
- Number of patients with fundic gland polyps and PPI use that have a higher gastric pH [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]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.
Biospecimen Retention: Samples With DNA
Blood draw: A fasting serum gastrin (FSG) level will be obtained to evaluate for hypergastrinemia at a follow-up visit after EGD. Approximately 4 cc's of blood is required. As many patients have been on long term PPI therapy, the FSG level is one method of determining whether the patient is on super-therapeutic levels of PPI which may need to be adjusted.
Biopsy specimens: Gastric fundic gland polyps found during endoscopy will have biopsies taken of the polyp, adjacent normal gastric body or fundus, and from the antrum.
Histological evaluation of biopsy specimens: Biopsies will be stained with H&E as well as neuroendocrine cell markers to assess for the presence of ECL cell hyperplasia. Paraffin-fixed tissue will be stored for future biological analysis. This will only be done after all clinically relevant analyses are completed and only if adequate tissue remains.
|Study Start Date:||October 2006|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Fundic Gland Polyps on PPI
Patients found to have fundic gland polyps on endoscopic evaluation that have also been prescribed and regularly take a proton pump inhibitor.
Fundic Gland Polyp not on PPI
Patients found to have fundic gland polyps on endoscopic evaluation that have not been prescribed a proton pump inhibitor.
Group 3 (Control Group)
Individuals who are prescribed proton pump inhibitor but are not found to have fundic gland polyps on endoscopic evaluation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130363
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Harold Frucht, MD||Columbia University|