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Sponsors and Collaborators: |
University of Rochester Takeda Pharmaceuticals North America |
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Information provided by: | University of Rochester |
ClinicalTrials.gov Identifier: | NCT00624546 |
Although the symptomatic and epithelial (histologic and endoscopic) response to antireflux therapy are well known and extensively studied, little is known of the genetic events occurring in response to proton pump inhibitor therapy. Preliminary data from our laboratory has shown, for example, that COX-2 expression is not only elevated in patients with gastroesophageal reflux disease but also can be correlated with pathologic esophageal acid exposure on 24 hour pH monitoring. Similar studies have suggested that antireflux surgery may normalize COX-2 gene expression. In contrast studies following ablation of dysplastic Barrett's epithelium have shown persistence of genetic changes associated with altered cellular function, despite the return of the histologic appearance to normal. Several key mediators of inflammation, metaplasia (Barrett's) and neoplasia have now been well characterized and shown to be important factors in the pathogenesis of esophageal injury. It is likely that successful antireflux therapy returns altered expression of these mediators toward normal although this hypothesis remains largely unexplored. The aim of this study is to investigate gene expression of key mediators of the spectrum of esophageal mucosal injury and the response to antireflux therapy.
Hypothesis: Antireflux therapy (proton pump inhibitor and surgical fundoplication) normalizes the expression of genes known to be involved in the pathogenesis of inflammation (esophagitis), metaplasia (Barrett esophagus) and neoplasia (adenocarcinoma).
Condition | Intervention |
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GERD Gastroesophageal Reflux |
Drug: Prevacid Solutabs Procedure: Antireflux surgery |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Effect of Antireflux Therapy on the Expression of Genes Known to be Important in Inflammation, Metaplasia and Neoplasia in Patients With GERD |
Esophageal mucosal biopsies
Estimated Enrollment: | 40 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
gerd patients
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Drug: Prevacid Solutabs
BID Prevacid Solutabs
Procedure: Antireflux surgery
Lap Nissen
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2
non gerd controls
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Aims: To determine the effects of antireflux therapy (pump inhibitor and surgical fundoplication) on gene expression of:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Subjects: (a) 20 patients with GERD and (b) 20 non-GERD controls.
Inclusion Criteria:
For patients with GERD
For non-GERD controls
Exclusion Criteria:
Contact: Jeffrey H Peters, MD | 585-275-2725 | jeffrey_peters@urmc.rochester.edu |
United States, New York | |
Strong Memorial Hospital | Recruiting |
Rochester, New York, United States, 14564 | |
Principal Investigator: Jeffrey H. Peters, MD |
Principal Investigator: | Jeffrey H Peters | University of Rochester |
Responsible Party: | University of Rochester ( Jeffrey H. Peters MD ) |
Study ID Numbers: | RSRB18199, rsrb18199 |
Study First Received: | December 28, 2007 |
Last Updated: | July 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00624546 History of Changes |
Health Authority: | United States: Institutional Review Board |
GERD gastroesophageal reflux antireflux surgery |
Barrett's Esophagus Esophagitis |
Deglutition Disorders Esophageal Motility Disorders Anti-Infective Agents Esophagitis Digestive System Diseases Esophageal Disorder |
Gastrointestinal Diseases Metaplasia Lansoprazole Esophageal Diseases Gastroesophageal Reflux Inflammation |
Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Gastrointestinal Agents Enzyme Inhibitors Gastroesophageal Reflux Pharmacologic Actions |
Esophageal Motility Disorders Deglutition Disorders Digestive System Diseases Therapeutic Uses Anti-Ulcer Agents Esophageal Diseases Lansoprazole |