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.
Status | Completed |
Enrollment | 99 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina Chapel Hill | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill | American Society for Gastrointestinal Endoscopy |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To characterize reflux symptomatology before and after radiofrequency ablation in subjects with dysplastic Barrett's Esophagus (BE). | 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 | No |
Secondary | To characterize the physiological and morphological properties of the neosquamous epithelium (NSE) | 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 ?2 and Student's t tests. | Enrollment | No |
Secondary | Correlate the physiologic and morphologic changes in the neosquamous epithelium (NSE) after ablation with the frequency and type of refluxate seen on pH-Impedance. | 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 | No |
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 |
NCT00586872 -
Endoscopic Mucosal Resection (EMR) in Barrett's Esophagus
|
||
Completed |
NCT00844077 -
Preliminary Longitudinal Validation of Biomarkers Predictive of Barrett's Esophagus
|
N/A | |
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 |