Fundic Gland Polyps and Proton Pump Inhibitor (PPI) Drugs

This study has been terminated.
(Poor Enrollment)
Sponsor:
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT01130363
First received: May 21, 2010
Last updated: June 29, 2012
Last verified: June 2012
  Purpose

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.


Condition
Fundic Gland Polyps

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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.


Enrollment: 23
Study Start Date: October 2006
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Individuals found to have fundic gland polyps on endoscopic evaluation and are on proton pump inhibitor (PPI), individuals found to have fundic gland polyps on endoscopic evaluation but are not on PPI or patients on PPI but had no fundic gland polyps found on endoscopic evaluation (control group).

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130363

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Harold Frucht, MD Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT01130363     History of Changes
Other Study ID Numbers: AAAC2805
Study First Received: May 21, 2010
Last Updated: June 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Proton Pump Inhibitor
Gastric carcinoid tumors
Gastric cancer
Fundic Gland Polyps

Additional relevant MeSH terms:
Polyps
Pathological Conditions, Anatomical
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014