Barrett's Esophagus Clinical Trial
Official title:
Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?
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.
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.
;
Observational Model: Cohort, Time Perspective: Cross-Sectional
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 |
NCT01281618 -
Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus
|
N/A | |
Completed |
NCT01439594 -
Optical Frequency Domain Imaging (OFDI) Assessment in Radiofrequency Ablation
|
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 |