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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Society for Gastrointestinal Endoscopy
Information provided by (Responsible Party):
Nicholas Shaheen, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01373125
First received: June 9, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition
Barrett's Esophagus
Intestinal Metaplasia
Gastroesophageal Reflux Disease (GERD)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?

Resource links provided by NLM:


Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • To characterize reflux symptomatology before and after radiofrequency ablation in subjects with dysplastic Barrett's Esophagus (BE). [ Time Frame: Enrollment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To characterize the physiological and morphological properties of the neosquamous epithelium (NSE) [ Time Frame: Enrollment ] [ Designated as safety issue: No ]
    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 χ2 and Student's t tests.

  • Correlate the physiologic and morphologic changes in the neosquamous epithelium (NSE) after ablation with the frequency and type of refluxate seen on pH-Impedance. [ Time Frame: Enrollment ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples With DNA

esophageal biopsies


Estimated Enrollment: 70
Study Start Date: June 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Radiofrequency Ablation (RFA)
Participants in this group are greater than or equal to 12 months status post radiofrequency ablation (RFA).
Radiofrequency Ablation Longitudinal (RFAL)
Participants in this group are part of a longitudinal portion of the study and are enrolled prior to their first radiofrequency ablation procedure and followed at 6 and 12 months after completion of RFA.
Gastroesophageal Reflux Disease (GERD)
Participants in this group have been diagnosed with gastroesophageal reflux disease.
Asymptomatic Controls (AC)
Participants in this group are asymptomatic controls and enrolled as part of the comparison group.

Detailed 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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Potential subjects will be identified by their gastrointestinal (GI) physician and approached by a study coordinator, nurse, or their GI physician regarding this study on the day of their scheduled procedure at UNC hospitals/GI clinic.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01373125

Locations
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
American Society for Gastrointestinal Endoscopy
Investigators
Principal Investigator: Nicholas Shaheen, MD, MPH UNC-Chapel Hill
  More Information

No publications provided

Responsible Party: Nicholas Shaheen, Professor of Medicine and Epidemiology Director, Center for Esophageal Diseases and Swallowing, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01373125     History of Changes
Other Study ID Numbers: 10-1951
Study First Received: June 9, 2011
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of North Carolina, Chapel Hill:
Barrett's Esophagus
Intestinal metaplasia
Gastroesophageal reflux disease (GERD)
Neosquamous epithelium
Radiofrequency ablation (RFA)

Additional relevant MeSH terms:
Barrett Esophagus
Gastroesophageal Reflux
Metaplasia
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Esophageal Motility Disorders
Deglutition Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014