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

NCT ID: NCT01373125

Last Updated: 2015-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 99 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2014-10-31

Brief 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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Radiofrequency Ablation (RFA)

Participants in this group are greater than or equal to 12 months status post radiofrequency ablation (RFA).

No interventions assigned to this group

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.

No interventions assigned to this group

Gastroesophageal Reflux Disease (GERD)

Participants in this group have been diagnosed with gastroesophageal reflux disease.

No interventions assigned to this group

Asymptomatic Controls (AC)

Participants in this group are asymptomatic controls and enrolled as part of the comparison group.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society for Gastrointestinal Endoscopy

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Nicholas Shaheen, MD

Professor of Medicine and Epidemiology Director, Center for Esophageal Diseases and Swallowing

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nicholas Shaheen, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC-Chapel Hill

Locations

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

10-1951

Identifier Type: -

Identifier Source: org_study_id