Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2014-02-28
2015-12-31
Brief Summary
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Detailed Description
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Approximately 100 subjects will be recruited, age greater than 18 years. Subjects will be recruited from OCF, OMC Kenner who are undergoing EGD for either 1) screening for Barrett's Esophagus because of long-standing GERD of greater than 5 years; 2) surveillance of known Barrett's Esophagus; or 3) therapy for known Barrett's Esophagus. They will be asked to volunteer for participation at the time of their EGD. These subjects are being recruited because of a high suspicion or known diagnosis of Barrett's Esophagus in this cohort.
Procedures
Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction. Photographs will be taken and digitally stored. Biopsies (which are part of the routine diagnosis and surveillance of Barrett's) will be targeted based on the microscopic images. The histologic findings on the biopsy specimens will be compared to the microscopic images to determine the accuracy of the probe-based microscopy in predicting pathology.
The time commitment for the patient is included in the time to undergo endoscopy and is roughly 30 minutes to an hour, including recovery time. The research will occur at OMC, Jefferson Highway and Ochsner Medical Center, Kenner.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Confocal laser endomicroscopy (pCLE)
Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction. Photographs will be taken and digitally stored. Biopsies (which are part of the routine diagnosis and surveillance of Barrett's) will be targeted based on the microscopic images. The histologic findings on the biopsy specimens will be compared to the microscopic images to determine the accuracy of the probe-based microscopy in predicting pathology.
Confocal laser endomicroscopy (pCLE)
Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction
Interventions
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Confocal laser endomicroscopy (pCLE)
Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction
Eligibility Criteria
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Inclusion Criteria
* currently undergoing EGD
* previous diagnosis of Barrett's Esophagus
* long-standing GERD of greater than 5 years
* undergoing therapy for previously diagnosed Barrett's Esophagus
Exclusion Criteria
19 Years
ALL
No
Sponsors
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Virendra Joshi
OTHER
Responsible Party
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Virendra Joshi
Virendra Joshi,MD
Principal Investigators
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Virendra Joshi, MD
Role: PRINCIPAL_INVESTIGATOR
Ochsner Health System
Locations
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Oschsner Medical Center-Kenner
Kenner, Louisiana, United States
Ochsner Medical Center-Jefferson Highway
New Orleans, Louisiana, United States
Countries
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Other Identifiers
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Barrett's Confocal
Identifier Type: -
Identifier Source: org_study_id
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