An interventional study of Confocal laser endomicroscopy (pCLE) in Barrett's Esophagus, sponsored by Virendra Joshi. Completed at 2 sites in United States. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2016-08-02.
Sponsored by Virendra Joshi · Not applicable, Interventional, and Treatment
The purpose of this study is to further validate the use of probe-based confocal laser endomicroscopy (pCLE) for the evaluation of Barrett's Esophagus and associated neoplasia in a larger patient base.
Subject Population
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.
310 studies on the registry are indexed under Barrett Esophagus; 64 are open to participants now.
This study's enrollment of 29 is below the median of 62 across 186 interventional studies indexed under Barrett Esophagus.
Browse Barrett Esophagus studies →This is the only study on the registry with Virendra Joshi as lead sponsor.
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Exclusion Criteria:
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.
Device: 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
Sensitivity and Specificity of probe based endomicroscopy as compared to histopathology in diagnosing Barrett's metaplasia
Time frame: 30 minutes up to an hour on average after undergoing endoscopy
Tissue and blood Biomarker evaluation in targeted biopsies obtained at endomicroscopy in patients diagnosed to have Barrett's metaplasia and dysplasia
Time frame: 30 minutes up to an hour on average after undergoing endoscopy
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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