Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

Study Overview
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Brief Summary
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Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

Official Title
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Confocal Endomicroscopy for Permeability of Esophageal Wall in Refractory Gastroesophageal Reflux Disease (GERD)

Conditions
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Barrett Esophagus, Gastro Esophageal Reflux, Erosive Esophagitis

Intervention / Treatment
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* Procedure: Confocal endomicroscopy
* Diagnostic Test: Endoscopic biopsies
* Diagnostic Test: Mucosal impedance (MI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Ability to give informed consent Exclusion Criteria: Pregnancy Esophageal varices Prior esophageal or gastric surgery Active gastrointestinal bleeding Evidence of esophageal malignancy Inability to provide informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Non-erosive reflux disease (NERD)<br>Patient's with GERD refractory to PPI with no evidence of erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed. | Procedure: Confocal endomicroscopy<br>* 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.<br>* Other names: cellvizio;Diagnostic Test: Endoscopic biopsies<br>* Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.<br>Diagnostic Test: Mucosal impedance (MI)<br>* 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.<br>|
| Active Comparator: Barrett's esophagus/erosive esophagitis<br>Patient's with Barrett's esophagus or with erosive esophagitis on endoscopy. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed. | Procedure: Confocal endomicroscopy<br>* 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.<br>* Other names: cellvizio;Diagnostic Test: Endoscopic biopsies<br>* Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.<br>Diagnostic Test: Mucosal impedance (MI)<br>* 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.<br>|
| Placebo Comparator: Control<br>Patient's with no h/o GERD or Barrett's esophagus who are undergoing endoscopy for non-GERD related indication. Confocal endomicroscopy, endoscopic biopsies and mucosal impedance (MI) will be performed. | Procedure: Confocal endomicroscopy<br>* 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.<br>* Other names: cellvizio;Diagnostic Test: Endoscopic biopsies<br>* Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.<br>Diagnostic Test: Mucosal impedance (MI)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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. |