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Trial #NCT01373125
Barrett's Esophagus Clinical Trials

Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?


Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?
Study ID: 10-1951; Source: University of North Carolina, Chapel Hill
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Definitions
Interventional trials
Determine whether experimental treatments or new ways of using known therapies are safe and effective under controlled environments.
Observational trials
Address health issues in large groups of people or populations in natural settings.
Recruiting
Participants are currently being recruited and enrolled.
Active, not recruiting
Study is ongoing (i.e., patients are being treated or examined), but enrollment has completed.
Not yet recruiting
Participants are not yet being recruited or enrolled.
Enrolling by invitation
Participants are being (or will be) selected from a predetermined population.
Completed
The study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred).
Withdrawn
Study halted prematurely, prior to enrollment of first participant.
Suspended
Recruiting or enrolling participants has halted prematurely but potentially will resume.
Terminated
Recruiting or enrolling participants has halted prematurely and will not resume; participants are no longer being examined or treated.
Status Active, not recruiting
Country United States
Study type Observational
Enrollment 70
Start date June 2011
Completion date September 2014
Phase N/A
Sponsor University of North Carolina, Chapel Hill
Summary:
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.
Description:
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.
Eligibility:
Gender: Both
Age: 18 Years - 80 Years
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
Outcome:
Primary outcome
  • To characterize reflux symptomatology before and after radiofrequency ablation in subjects with dysplastic Barrett's Esophagus (BE).
    To characterize reflux symptomatology before and after radiofrequency ablation in subjects with dysplastic BE. We will compare before and after gastroesophageal reflux disease (GERD) symptom assessment scale (GSAS) symptom scores using paired Student's t tests. As an exploratory analysis, we will further stratify the data by PPI use (once- vs. twice-daily.
    Time frame: Enrollment
Secondary outcome
  • Correlate the physiologic and morphologic changes in the neosquamous epithelium (NSE) after ablation with the frequency and type of refluxate seen on pH-Impedance.
    We will initially plot esophageal acid exposure (total time with esophageal pH<4) against intercellular space, total electrical resistance (RT), fluorescein flux and gastroesophageal reflux disease (GERD) sysmptom assessment scale (GSAS) scores. R values will be generated. Regression models using each of the 3 physiologic measures (RT, fluorescein, and intercellular space) as the response variable, and acid exposure and number of non-acid reflux events as predictor variables will be generated to define the relationship between reflux type and findings.
    Time frame: Enrollment
  • To characterize the physiological and morphological properties of the neosquamous epithelium (NSE)
    To characterize the physiological and morphological properties of the NSE, compared to native esophageal squamous epithelium in healthy controls and subjects with non-Barrett's Esophagus (BE) gastroesophageal reflux disease (GERD). We will compare the physiologic measures of NSE (intercellular space, total electrical resistance (RT), and fluorescein flux) to positive and negative controls using ?2 and Student's t tests.
    Time frame: Enrollment
Contacts:
  • Nicholas Shaheen, MD, MPH; UNC-Chapel Hill (Principal Investigator)
Location Country Status
University of North Carolina Chapel Hill Chapel Hill, North Carolina United States
Sponsors:
  • University of North Carolina, Chapel Hill - (Lead Sponsor)
  • American Society for Gastrointestinal Endoscopy - Collaborator

Related trials: Terms
  • Intestinal metaplasia
  • Radiofrequency ablation (RFA)
  • Barrett's Esophagus
  • Neosquamous epithelium
  • Gastroesophageal reflux disease (GERD)
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