The hypothesis is that the addition of a transparent cap to the end of the endoscope will increase the detection and diagnostic yield of visible lesions in Barrett's esophagus. Thus, the goal of this tandem design trial is to compare the diagnostic yield (DY) of cap assisted endoscopy with that of conventional endoscopy using high definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI) in patients with Barrett's esophagus.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
100
-The second endoscopist will be blinded to the results of the initial exam.
-The second endoscopist will be blinded to the results of the initial exam.
Washington University School of Medicine
St Louis, Missouri, United States
Number of Participants Who Had a Diagnostic Yield Obtained
-Diagnostic yield is defined as Barrett's esophagus lesions that were identified and confirmed histologically as low grade dysplasia, high grade dysplasia, intramucosal cancer, or invasive adenocarcinoma
Time frame: At the time of procedure (day 1)
Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap
Time frame: At the time of procedure (day 1)
Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma
Time frame: At the time of procedure (day 1)
Total Procedure Duration in Seconds
Time frame: At the time of procedure (day 1)
Safety as Measured by Number of Participants With Procedure-related Adverse Events
* The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. * Adverse events were collected for the entire procedure as a whole and for 48 hours after the procedure and were not separately collected for each part of the procedure (EGD without CAP versus EGD with CAP).
Time frame: Through 48 hours after EGD
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.