Neoplasms

Digestive System Diseases

All Conditions

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.

-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.

-The second endoscopist will be blinded to the results of the initial exam.

Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)

Olympus Disposable Distal Attachment Cap

Vladimir M Kushnir, M.D.

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.

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

-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

* 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).

Washington University School of Medicine

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).

Arm 1: EGD With Cap First, Followed by EGD Without Cap

Arm 2: EGD Without Cap First, Followed by EGD With Cap

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Vladimir M. Kushnir, M.D.

-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)

EGD Without CAP

-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)

EGD With CAP

Participants had to have visible lesions to be evaluable for this outcome measure.

Number of Participants Who Had a Diagnostic Yield Obtained

Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap

Out of the 100 enrolled participants, there were 2 participants with missing pathology reports.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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	NCT03417570	Barrett Esophag...	Esophagogastrod... Olympus Disposa...	18 Years -	Washington University School of Medicine
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	NCT03417570	Barrett Esophag...	Esophagogastrod... Olympus Disposa...	18 Years -	Washington University School of Medicine
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	NCT03417570	Barrett Esophag...	Esophagogastrod... Olympus Disposa...	18 Years -	Washington University School of Medicine

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