Gastro Esophageal Reflux, Barrett Esophagus, Erosive Esophagitis
Conditions
Brief summary
Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)
Interventions
PROCEDUREConfocal endomicroscopy
Confocal laser endomicroscopy (CLE) permits real-time in-vivo histologic analysis of esophageal mucosa at the time of upper endoscopy. The technology is based on the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. Because CLE relies upon tissue fluorescence, intravenous fluorescein is generally used to highlight the vasculature and intercellular spaces of the tissue being examined.
DIAGNOSTIC_TESTEndoscopic biopsies
Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.
DIAGNOSTIC_TESTMucosal impedance (MI)
MI balloon measures epithelial impedance along a 10 cm length of esophagus. The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth. The balloon will be inflated so that the sensors contact the esophageal mucosa. After MI measurements are obtained, the balloon will be deflated and withdrawn.
Sponsors
Hunter Holmes McGuire VA Medical Center
McGuire Research Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)
Masking description
Investigator in the lab performing Ussing's chamber analysis will be blinded to the diagnosis of the patient
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age \> 18 years 2. Ability to give informed consent
Exclusion criteria
1. Pregnancy 2. Esophageal varices 3. Prior esophageal or gastric surgery 4. Active gastrointestinal bleeding 5. Evidence of esophageal malignancy 6. Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Correlation between the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) with esophageal permeability (i.e. - epithelial barrier function). | Through study completion, an average of 1 year. |
Secondary
| Measure | Time frame |
|---|---|
| Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with Barrett's esophagus and controls | Through study completion, an average of 1 year. |
| Compare the time from intravenous injection of fluorescein to visualization of fluorescein on probe based confocal endomicroscopy (pCLE) in patients with symptoms of refractory GERD and Barrett's esophagus | Through study completion, an average of 1 year. |
| Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and Barrett's esophagus | Through study completion, an average of 1 year. |
| Correlation between the Ussing's chamber findings (esophageal permeability) and confocal endomicroscopy findings of patients with symptoms of refractory GERD and controls | Through study completion, an average of 1 year. |
| Correlation between the Ussing's chamber findings (esophageal permeability) and Mucosal impedance findings of patients with symptoms of refractory GERD and controls | Through study completion, an average of 1 year. |
Countries
United States
Contacts
Primary ContactPritesh R Mutha, MD,MPH
Outcome results
None listed