View Clinical Trial (Medical Research Study)
Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?
| City: |
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Chapel Hill |
| State: |
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North Carolina |
| Zip Code: |
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27599 |
| Conditions: |
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Barrett's Esophagus - Intestinal Metaplasia - Gastroesophageal Reflux Disease (GERD) |
| Purpose: |
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The investigators propose a study comparing the morphological and functional aspects of the
neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE)
to that of native squamous epithelium in normal controls as well as gastroesophageal reflux
disease (GERD), non-Barrett's Esophagus (BE) subjects.
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| Study Summary: |
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Purpose: We propose a study comparing the morphological and functional aspects of the
neosquamous epithelium (NSE) after ablative therapy for dysplastic Barrett's esophagus (BE)
to that of native squamous epithelium in normal controls as well as gastroesophageal reflux
disease (GERD), non-BE subjects.
Participants: Eligible subjects will be women and men between the ages of 18-80, with one
of the following:
1. Two or greater cm of dysplastic BE, who will undergo or have undergone radiofrequency
ablation for BE at UNC, or
2. Diagnosed with GERD per a gastrointestinal (GI) physician undergoing upper endoscopy
for other indications at UNC, or
3. Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper
endoscopy for other indications at UNC.
Procedures (methods): Esophageal biopsies will be obtained specifically for research
purposes before ablation therapy or, in subjects not receiving ablative therapy, after
completion of the clinically indicated procedure and before withdrawal of the endoscope.
Information from the medical record or from patient interview will be obtained regarding
diagnosis (Barrett's esophagus, GERD, etc), and a questionnaire administered regarding the
duration and frequency of reflux symptoms and complications of reflux disease. Subjects who
are enrolled in the pre-ablation group will have additional biopsies and questionnaires
administered during scheduled follow-up visits. On the last follow-up visit, this group
will also undergo impedance-pH testing using standard methods, to assess for degree of
control of esophageal acid exposure, and for number, duration and symptom correlation of
non-acid reflux events.
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| Criteria: |
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Inclusion:
Eligible subjects will be mentally competent women and men between the ages of 18-80, able
to speak and read English and who meet one of the following criteria:
- Two or greater cm of dysplastic Barrett's Esophagus (BE), who will undergo or have
undergone radiofrequency ablation (RFA) for BE at the University of North Carolina,
Chapel Hill (UNC), or
- Diagnosed with gastroesophageal reflux disease (GERD) per a GI physician undergoing
upper endoscopy (EGD) for other indications at UNC, or
- Non-GERD controls per a GI physician with normal esophageal mucosa undergoing upper
endoscopy for other indications at UNC.
Exclusion:
- Subjects with a bleeding diathesis or other contraindication of endoscopic biopsy.
- Current use of warfarin, heparin, and/or low molecular weight heparin (requires
discontinuation of medication 5 days prior to and 7 days after EGD).
- Pregnant women
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| NCT ID: |
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NCT01373125 |
| Primary Contact: |
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Principal Investigator
Nicholas Shaheen, MD, MPH
UNC-Chapel Hill
Susan Bream
Phone: 919-966-7655
Email: susan_bream@med.unc.edu
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| Backup Contact: |
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N/A |
| Location Contact: |
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Chapel Hill, North Carolina 27599
United States
Susan Bream
Phone: 919-966-7655
Email: susan_bream@med.unc.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 19, 2013 |
| Modifications to this listing: |
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