Clinical Trial: Confocal Laser Probe to Treat Barrett's Esophagus
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Real-Time Evaluation of Barrett's Esophagus by Confocal Laser Probe-based Microscopy
Brief Summary: 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.
Detailed Summary:
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.
Sponsor: Virendra Joshi
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: 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 ]
Original Secondary Outcome: Same as current
Information By: Ochsner Health System
Dates:
Date Received: January 21, 2014
Date Started: February 2014
Date Completion:
Last Updated: July 28, 2016
Last Verified: July 2016
