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

The Washington University

Status: Terminated

Conditions: Barrett Esophagus

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03417570

201708210

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Arm 1: EGD with cap first, followed by EGD without cap

Experimental group

Description:

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

Treatment:

Device: Olympus Disposable Distal Attachment Cap

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

Arm 2: EGD without cap first, followed by EGD with cap

Experimental group

Description:

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

Treatment:

Device: Olympus Disposable Distal Attachment Cap

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