Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/30/2016 |
| Start Date: | August 2015 |
| End Date: | June 2018 |
| Contact: | Virendra Joshi, MD |
| Email: | vjoshi@ochsner.org |
| Phone: | 504-842-7690 |
Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection (CENERDD)
Primary Objective:
Evaluate response to NERD treatment between patients with normal endomicroscopy findings
compared with patients with abnormal endomicroscopy findings.
Secondary Objectives:
To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating
dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.
Quality of life at study entry and end of study. Compare two medications under study within
each group as a subgroup analysis.
Evaluate response to NERD treatment between patients with normal endomicroscopy findings
compared with patients with abnormal endomicroscopy findings.
Secondary Objectives:
To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating
dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.
Quality of life at study entry and end of study. Compare two medications under study within
each group as a subgroup analysis.
The purpose of this study is to evaluate response to non-erosive reflux disease (NERD)
treatment between patients with normal endomicroscopy findings compared with patients with
abnormal endomicroscopy findings. The researchers will compare two different drug regimens
for the NERD subjects to evaluate their effectiveness in reducing NERD-related symptoms. In
addition, the researchers will be testing the function and effectiveness of the confocal
endomicroscopy procedure to be used during the study. Researchers will be continuing to
assess the status, symptoms, and any changes associated with the symptoms subjects are
experiencing.
The confocal endomicroscopy procedure utilizes a powerful microscope that is used during an
endoscopy. An endoscopy is a procedure that allows us to scope/view the inside of the
esophagus and stomach using a camera in precise detail.
An endoscopy procedure and measurements of acid in the esophagus have been used to determine
if the investigators think acid is causing the symptoms. Traditionally, acid blocking
medications called proton pump inhibitors (PPIs such as Esomeprazole, Lansoprazole,
Omeprazole, and Pantoprazole), or medications such as Sucralfate have been used to treat the
symptoms of NERD.
The medical community believes that these symptoms are due to increased spaces between the
cells that make up the esophagus. They can directly see those spaces using the confocal
endomicroscopy.
Patients are asked to participate in this study if they are 18 years of age or older and
have typical symptoms for patients diagnosed with NERD that have not responded to the first
attempted medication.
treatment between patients with normal endomicroscopy findings compared with patients with
abnormal endomicroscopy findings. The researchers will compare two different drug regimens
for the NERD subjects to evaluate their effectiveness in reducing NERD-related symptoms. In
addition, the researchers will be testing the function and effectiveness of the confocal
endomicroscopy procedure to be used during the study. Researchers will be continuing to
assess the status, symptoms, and any changes associated with the symptoms subjects are
experiencing.
The confocal endomicroscopy procedure utilizes a powerful microscope that is used during an
endoscopy. An endoscopy is a procedure that allows us to scope/view the inside of the
esophagus and stomach using a camera in precise detail.
An endoscopy procedure and measurements of acid in the esophagus have been used to determine
if the investigators think acid is causing the symptoms. Traditionally, acid blocking
medications called proton pump inhibitors (PPIs such as Esomeprazole, Lansoprazole,
Omeprazole, and Pantoprazole), or medications such as Sucralfate have been used to treat the
symptoms of NERD.
The medical community believes that these symptoms are due to increased spaces between the
cells that make up the esophagus. They can directly see those spaces using the confocal
endomicroscopy.
Patients are asked to participate in this study if they are 18 years of age or older and
have typical symptoms for patients diagnosed with NERD that have not responded to the first
attempted medication.
Inclusion Criteria:
1. Individuals older than 18 years who score a 12 or greater on the Reflux Disease
Questionnaire and have failed a four week trial of daily proton pump inhibitor.
2. Subjects without gastroesophageal reflux disease (GERD) undergoing upper
endomicroscopy for other indications will be recruited into study as controls.
Exclusion Criteria:
1. Barrett's esophagus
2. Use of twice daily proton pump inhibitor within 4 weeks of study entry
3. Esophageal varices
4. Coagulopathy (aspirin, NSAIDS and Plavix are allowed. Coumadin, Xarelto, heparin are
not allowed.)
5. Gastrointestinal cancer or mass
6. Previous surgery involving the esophagus, stomach or duodenum
7. Pregnancy
8. Allergy to either sucralfate or proton pump inhibitors
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