Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs
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|