Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs
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|ClinicalTrials.gov Identifier: NCT01130363|
Recruitment Status : Terminated (Poor Enrollment)
First Posted : May 26, 2010
Last Update Posted : July 2, 2012
|Condition or disease|
|Fundic Gland Polyps|
|Study Type :||Observational|
|Actual Enrollment :||23 participants|
|Observational Model:||Case Control|
|Official Title:||Determination of a Possible Association of Fundic Gland Polyps With the Use of Proton Pump Inhibitor Drugs|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
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.
- Number of patients with fundic gland polyps and PPI use that have a higher gastric pH [ Time Frame: 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130363
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|Principal Investigator:||Harold Frucht, MD||Columbia University|