Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01373125
Study type	Observational
Source	University of North Carolina, Chapel Hill
Contact
Status	Completed
Phase	N/A
Start date	June 2011
Completion date	October 2014

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02864043` - Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System	N/A
Recruiting	`NCT02018367` - Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Adenocarcinoma	Phase 2
Terminated	`NCT01572987` - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus	N/A
Terminated	`NCT01976351` - Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus	N/A
Terminated	`NCT00526786` - Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus	Phase 4
Completed	`NCT01401699` - Optical Coherence Tomography (OCT) Based Screening of Esophagus and Gastroesophageal Junction	N/A
Completed	`NCT02106910` - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy	N/A
Suspended	`NCT01580631` - Narrow Band Imaging Project on Barrett's Esophagus
Completed	`NCT01439633` - Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus	N/A
Completed	`NCT02879721` - Expression and Function of the Renin-Angiotensin System in the Esophagus	Phase 0
Completed	`NCT01439594` - Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation	N/A
Completed	`NCT01281618` - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus	N/A
Completed	`NCT00844077` - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus	N/A
Completed	`NCT00586872` - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
Completed	`NCT00588575` - Ramanspectroscopy in Barrett's Esophagus
Recruiting	`NCT00288119` - Genetic Determinants of Barrett's Esophagus and Esophageal Adenocarcinoma
Completed	`NCT02579460` - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition	N/A
Completed	`NCT03813381` - CAlorie and Protein REstriction PROgram in Barrett's Esophagus Patients (CARE-PRO).	N/A
Not yet recruiting	`NCT02033070` - Patient Registry: Radio Frequency Ablation of Barrett's Esophagus Using HALO System	N/A
Completed	`NCT01961778` - Comparison of Treatments for Barrett's Esophagus With High-Grade Dysplasia/Early Adenocarcinoma	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms