Barrett's Esophagus Clinical Trial
Is the Neosquamous Epithelium "Normal" Following Endoscopic Ablation of Dysplastic Barrett's Esophagus?
|Source||University of North Carolina, Chapel Hill|
|Start date||June 2011|
|Completion date||October 2014|
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
|Recruiting||NCT02864043 - Barrett's Dysplasia Detection Pilot Trial Using the NvisionVLE® Imaging System||N/A|
|Recruiting||NCT02947971 - Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System||N/A|
|Recruiting||NCT02018367 - Accuracy, Yield and Clinical Impact of a Low-Cost HRME in the Early Diagnosis of Esophageal Neoplasia||Phase 1|
|Terminated||NCT01572987 - Endoscopic Resection or Ablation for Patients With Dysplasia or Cancer Requiring Treatment of Barrett's Esophagus||Phase 3|
|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||Phase 1|
|Recruiting||NCT02560623 - Minimally-Invasive Detection of Barrett's Esophagus and Barrett's Esophagus Related Dysplasia/Carcinoma||N/A|
|Enrolling by invitation||NCT02106910 - Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy||N/A|
|Recruiting||NCT01580631 - Narrow Band Imaging Project on Barrett's Esophagus||N/A|
|Completed||NCT01439633 - Optical Frequency Domain Imaging (OFDI) Surveillance and Image Guided Biopsy of the Esophagus||Phase 1|
|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||Phase 1|
|Completed||NCT01281618 - Influence of Acid Reflux on Stromal Epithelial Interaction in Barrett's Esophagus||N/A|
|Enrolling by invitation||NCT00586872 - Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus||N/A|
|Completed||NCT00844077 - Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus||N/A|
|Recruiting||NCT00288119 - Familial Barrett's Esophagus||N/A|
|Completed||NCT00588575 - Ramanspectroscopy in Barrett's Esophagus||N/A|
|Enrolling by invitation||NCT02579460 - Reflux-Induced Oxidative Stress in Barrett's Esophagus: Response, Repair, and Epithelial-Mesenchymal-Transition||N/A|
|Recruiting||NCT01961778 - Comparison of Radiofrequency Ablation and Cryotherapy for the Treatment of Barrett's Esophagus With High-Grade Dysplasia and/or Early Adenocarcinoma||N/A|