Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study

Study Overview
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Brief Summary
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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.

Official Title
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Cap Assisted Upper Endoscopy Versus High Definition White Light Endoscopy and Narrow Band Imaging Alone In The Detection Of Visible Lesions Barrett's Esophagus: A Randomized Tandem Study

Conditions
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Barrett Esophagus

Intervention / Treatment
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* Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)
* Device: Olympus Disposable Distal Attachment Cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be at least 18 years of age. Must be patients undergoing standard of care EGD for the confirmation of dysplasia in BE or EET for dysplasia in BE. Must be able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: Pregnant or breastfeeding. Prior endoscopic treatment for BE. Unable to tolerate sedation due to medical comorbidities.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: EGD with cap first, followed by EGD without cap<br>-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period. | Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)<br>* -The second endoscopist will be blinded to the results of the initial exam.<br>* Other names: EGD;Device: Olympus Disposable Distal Attachment Cap<br>* -The second endoscopist will be blinded to the results of the initial exam.<br>* Other names: Cap;|
| Experimental: Arm 2: EGD without cap first, followed by EGD with cap<br>-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period. | Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)<br>* -The second endoscopist will be blinded to the results of the initial exam.<br>* Other names: EGD;Device: Olympus Disposable Distal Attachment Cap<br>* -The second endoscopist will be blinded to the results of the initial exam.<br>* Other names: Cap;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | At the time of procedure (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap |  | At the time of procedure (day 1) | 
| Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma |  | At the time of procedure (day 1) | 
| Total Procedure Duration in Seconds |  | 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). | Through 48 hours after EGD |