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 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 Overview

• Status: Terminated
• Conditions: Barrett Esophagus
• Intervention / Treatment: 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
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: EGD with cap first, followed by EGD without cap; -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); -The second endoscopist will be blinded to the results of the initial exam.; Other Names: EGD; Device: Olympus Disposable Distal Attachment Cap; -The second endoscopist will be blinded to the results of the initial exam.; Other Names: Cap
Experimental: Arm 2: EGD without cap first, followed by EGD with cap; -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); -The second endoscopist will be blinded to the results of the initial exam.; Other Names: EGD; Device: Olympus Disposable Distal Attachment Cap; -The second endoscopist will be blinded to the results of the initial exam.; Other Names: Cap

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Vladimir M Kushnir, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2017
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): November 17, 2021

Study Registration Dates

• First Submitted: January 25, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 31, 2018

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: 201708210

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No