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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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03417570
Recruitment Status : Active, not recruiting
First Posted : January 31, 2018
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Barrett Esophagus Procedure: Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI) Device: Olympus Disposable Distal Attachment Cap Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 22, 2017
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


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.
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 Name: EGD

Device: Olympus Disposable Distal Attachment Cap
-The second endoscopist will be blinded to the results of the initial exam.
Other Name: 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
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 Name: EGD

Device: Olympus Disposable Distal Attachment Cap
-The second endoscopist will be blinded to the results of the initial exam.
Other Name: Cap




Primary Outcome Measures :
  1. Compare the diagnostic yield of EGD with HD-WLE and NBI to the diagnostic yield of cap-assisted EGD with HD-WLE and NBI [ Time Frame: At the time of procedure (day 1) ]
    -Diagnostic yield is defined as the proportion of EGD in which visible Barrett's esophagus lesions were identified and confirmed histologically as low grade dysplasia, high grade dysplasia, intramucosal cancer, or invasive adenocarcinoma


Secondary Outcome Measures :
  1. Number of visible lesions detected per person in EGD with cap versus without cap [ Time Frame: At the time of procedure (day 1) ]
  2. Number of cases of high grade dysplasia and esophageal adenocarcinoma detected by the EGD with cap versus the EGD without cap [ Time Frame: At the time of procedure (day 1) ]
  3. Total procedure duration in minutes [ Time Frame: At the time of procedure (day 1) ]
  4. Safety as measured by procedure-related adverse events [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Presence of erosive esophagitis.
  • Prior endoscopic treatment for BE.
  • Unable to tolerate sedation due to medical comorbidities.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417570


Locations
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United States, California
University of California - Los Angeles (UCLA)
Los Angeles, California, United States, 90095
United States, Colorado
University of Colorado
Denver, Colorado, United States, 80045
United States, Illinois
Northwestern University
Evanston, Illinois, United States, 60208
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Vladimir M Kushnir, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03417570    
Other Study ID Numbers: 201708210
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: June 1, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases