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

Barrett Esophagus Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03417570
• Other study ID #: 201708210
• Status: Terminated
• Phase: N/A
• Start date: December 22, 2017
• Est. completion date: November 17, 2021

Study information

• Verified date: August 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: November 17, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

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.

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap		At the time of procedure (day 1)
Secondary	Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma		At the time of procedure (day 1)
Secondary	Total Procedure Duration in Seconds		At the time of procedure (day 1)
Secondary	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

External Links

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