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

September 21, 2015 updated by: Nicholas Shaheen, MD, University of North Carolina, Chapel Hill
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

99

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize reflux symptomatology before and after radiofrequency ablation in subjects with dysplastic Barrett's Esophagus (BE).
Time Frame: Enrollment
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.
Enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize the physiological and morphological properties of the neosquamous epithelium (NSE)
Time Frame: Enrollment
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.
Enrollment
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
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.
Enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of North Carolina, Chapel Hill

Collaborators

American Society for Gastrointestinal Endoscopy

Investigators

  • Principal Investigator: Nicholas Shaheen, MD, MPH, UNC-Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

June 13, 2011

First Posted (Estimate)

June 14, 2011

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-1951

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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