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Effect of Antireflux Therapy on the Expression of Genes Known to be Important in Inflammation, Metaplasia and Neoplasia in Patients With GERD


N/A
18 Years
N/A
Open (Enrolling)
Both
GERD, Gastroesophageal Reflux

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Trial Information

Effect of Antireflux Therapy on the Expression of Genes Known to be Important in Inflammation, Metaplasia and Neoplasia in Patients With GERD


Aims: To determine the effects of antireflux therapy (pump inhibitor and surgical
fundoplication) on gene expression of:

1. inflammation: IL-8, IFN-g, TNF-a.

2. intestinal metaplasia: CDX-1/2, MUC2 and Sonic hedgehog.

3. Neoplasia: Cox-2, VEGF, and EGFR.


Inclusion Criteria:



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

Exclusion Criteria:

- 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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

gene expression

Outcome Time Frame:

before and after treatment

Safety Issue:

No

Principal Investigator

Jeffrey H Peters

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Institutional Review Board

Study ID:

RSRB18199

NCT ID:

NCT00624546

Start Date:

January 2009

Completion Date:

December 2014

Related Keywords:

  • GERD
  • Gastroesophageal Reflux
  • GERD
  • gastroesophageal reflux
  • antireflux surgery
  • Barrett's
  • Esophagus
  • Esophagitis
  • Gastroesophageal Reflux

Name

Location

Strong Memorial HospitalRochester, New York  14642