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

Not Applicable

Terminated

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

• Registration Number: NCT03417570
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-22
• Study First Submitted: 2018-01-25
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-31
• Primary Completion: 2021-11-15
• Study Completion: 2021-11-17
• Results First Submitted: 2022-06-02
• Results First Submitted QC: 2022-07-28
• Results First Posted: 2022-07-29
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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.

Read More

Exclusion Criteria

• Pregnant or breastfeeding.
• Prior endoscopic treatment for BE.
• Unable to tolerate sedation due to medical comorbidities.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1: EGD with cap first, followed by EGD without cap	Olympus Disposable Distal Attachment Cap	-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.
Arm 2: EGD without cap first, followed by EGD with cap	Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)	-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.
Arm 1: EGD with cap first, followed by EGD without cap	Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)	-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.
Arm 2: EGD without cap first, followed by EGD with cap	Olympus Disposable Distal Attachment Cap	-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Had a Diagnostic Yield Obtained	At the time of procedure (day 1)	-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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma	At the time of procedure (day 1)
Safety as Measured by Number of Participants With Procedure-related Adverse Events	Through 48 hours after EGD	* 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).
Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap	At the time of procedure (day 1)
Total Procedure Duration in Seconds	At the time of procedure (day 1)

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States