Back to resultsCap 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
Primary Purpose
Barrett Esophagus
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)
Olympus Disposable Distal Attachment Cap
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett Esophagus
Eligibility Criteria
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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1: EGD with cap first, followed by EGD without cap
Arm 2: EGD without cap first, followed by EGD with cap
Arm Description
-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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap
Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma
Total Procedure Duration in Seconds
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).
Full Information
NCT ID
NCT03417570
First Posted
January 25, 2018
Last Updated
August 1, 2022
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03417570
Brief Title
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
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
Futility
Study Start Date
December 22, 2017 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
November 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: EGD with cap first, followed by EGD without cap
Arm Type
Experimental
Arm Description
-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.
Arm Title
Arm 2: EGD without cap first, followed by EGD with cap
Arm Type
Experimental
Arm Description
-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.
Intervention Type
Procedure
Intervention Name(s)
Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)
Other Intervention Name(s)
EGD
Intervention Description
-The second endoscopist will be blinded to the results of the initial exam.
Intervention Type
Device
Intervention Name(s)
Olympus Disposable Distal Attachment Cap
Other Intervention Name(s)
Cap
Intervention Description
-The second endoscopist will be blinded to the results of the initial exam.
Primary Outcome Measure Information:
Title
Number of Participants Who Had a Diagnostic Yield Obtained
Description
-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
Time Frame
At the time of procedure (day 1)
Secondary Outcome Measure Information:
Title
Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap
Time Frame
At the time of procedure (day 1)
Title
Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma
Time Frame
At the time of procedure (day 1)
Title
Total Procedure Duration in Seconds
Time Frame
At the time of procedure (day 1)
Title
Safety as Measured by Number of Participants With Procedure-related Adverse Events
Description
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).
Time Frame
Through 48 hours after EGD
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vladimir M Kushnir, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
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
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