NCT00624546

Brief Summary

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).

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2007

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 27, 2008

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

October 26, 2015

Status Verified

October 1, 2015

Enrollment Period

5 years

First QC Date

December 28, 2007

Last Update Submit

October 23, 2015

Conditions

GERDGastroesophageal Reflux

Keywords

GERDgastroesophageal refluxantireflux surgeryBarrett'sEsophagusEsophagitis

Outcome Measures

Primary Outcomes (1)

  • gene expression

    before and after treatment

Study Arms (2)

1

gerd patients

Drug: Prevacid SolutabsProcedure: Antireflux surgery

2

non gerd controls

Interventions

Prevacid SolutabsDRUG

BID Prevacid Solutabs

1
Antireflux surgeryPROCEDURE

Lap Nissen

1

Eligibility Criteria

Age18 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects: (a) 20 patients with GERD and (b) 20 non-GERD controls.

You may qualify if:

  • For patients with GERD
  • Patients referred for anti-reflux surgery
  • On PPI therapy for at least 6 months
  • Positive ambulatory pH monitoring (%time pH\<4 \> 4.7)
  • Age greater than 18 years old.
  • Both genders
  • For non-GERD controls
  • Negative ambulatory pH monitoring OR
  • Upper endoscopy performed for non-GERD symptoms.
  • Age greater than 18 years old.
  • Both genders

You may not qualify if:

  • Prior foregut surgery
  • Contra-indications for operation (poor clinical status, etc.)
  • Contra-indications for endoscopy and biopsy (esophageal or gastric varices, therapeutic anticoagulation with Coumadin or Heparin, etc.)
  • Unwillingness to participate in all of the follow-up studies
  • Pregnancy
  • Patients using medications that may interfere with PPIs pharmacokinetics (sucralfate, ketoconazole (Nizoral), ampicillin (Omnipen, Principen), digoxin (Lanoxin, Lanoxicaps), and iron (Feosol, Mol-Iron, Fergon, Femiron).
  • Patients using medications that may interfere with gene expression (Immunosuppressants, Aspirin, NSAIDs, Corticosteroids).
  • Patients with diseases that may interfere with gene expression (autoimmune diseases, diseases that course with immunosuppression).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Strong Memorial Hospital

Rochester, New York, 14564, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Esophageal mucosal biopsies

MeSH Terms

Conditions

Gastroesophageal RefluxEsophagitis

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesGastroenteritis

Study Officials

  • Jeffrey H Peters

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Chair of the Department of Surgery

Study Record Dates

First Submitted

December 28, 2007

First Posted

February 27, 2008

Study Start

January 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

October 26, 2015

Record last verified: 2015-10

Locations

US(1)