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

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03417570
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 46.9
• Patients Per Site Per Month: 2.1

Study Details

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.

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Crossover 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: Dec 22, 2017
• Actual Primary Completion Date: Nov 15, 2021
• Actual Study Completion Date: Nov 17, 2021

Arms and Interventions

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 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	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

Outcome Measures

Primary Outcome Measures

1. 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

1. Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap [At the time of procedure (day 1)]

2. Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma [At the time of procedure (day 1)]

3. Total Procedure Duration in Seconds [At the time of procedure (day 1)]

4. 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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Washington University School of Medicine	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

• Washington University School of Medicine

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 25, 2021

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03417570
• Other Study ID Numbers: 201708210
• First Posted: Jan 31, 2018
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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: Barrett Esophagus

Study Results

Participant Flow

Arm/Group Title	Arm 1: EGD With Cap First, Followed by EGD Without Cap	Arm 2: EGD Without Cap First, Followed by EGD With Cap
Arm/Group Description	-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap.	-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap
Period Title: EGD w/Cap 1st-approximately 80 Seconds
STARTED	50	0
COMPLETED	50	0
NOT COMPLETED	0	0
Period Title: EGD w/Cap 1st-approximately 80 Seconds
STARTED	0	50
COMPLETED	0	50
NOT COMPLETED	0	0
Period Title: EGD w/Cap 1st-approximately 80 Seconds
STARTED	0	50
COMPLETED	0	50
NOT COMPLETED	0	0
Period Title: EGD w/Cap 1st-approximately 80 Seconds
STARTED	50	0
COMPLETED	50	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Arm 1: EGD With Cap First, Followed by EGD Without Cap	Arm 2: EGD Without Cap First, Followed by EGD With Cap	Total
Arm/Group Description	-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap.	-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap	Total of all reporting groups
Overall Participants	50	50	100
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	65.5	66	66
Sex: Female, Male (Count of Participants)
Female	7 14%	8 16%	15 15%
Male	43 86%	42 84%	85 85%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	50 100%	49 98%	99 99%
Unknown or Not Reported	0 0%	1 2%	1 1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 2%	0 0%	1 1%
White	49 98%	50 100%	99 99%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	50 100%	50 100%	100 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

Participants had to have visible lesions to be evaluable for this outcome measure.

Arm/Group Title	EGD Without CAP	EGD With CAP
Arm/Group Description	-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)	-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
Measure Participants	56	60
Count of Participants [Participants]	56 112%	60 120%

2. Secondary Outcome

Title	Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap
Time Frame	At the time of procedure (day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EGD Without CAP	EGD With CAP
Arm/Group Description	-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)	-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
Measure Participants	100	100
Count of Participants [Participants]	56 112%	60 120%

3. Secondary Outcome

Title	Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma
Time Frame	At the time of procedure (day 1)

Outcome Measure Data

Analysis Population Description

Out of the 100 enrolled participants, there were 2 participants with missing pathology reports.

Arm/Group Title	EGD Without CAP	EGD With CAP
Arm/Group Description	-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)	-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
Measure Participants	98	98
Count of Participants [Participants]	22 44%	23 46%

4. Secondary Outcome

Title	Total Procedure Duration in Seconds
Time Frame	At the time of procedure (day 1)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	EGD Without CAP	EGD With CAP
Arm/Group Description	-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)	-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
Measure Participants	100	100
Mean (Standard Deviation) [seconds]	160.9 (74.6)	159.8 (73.4)

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Arm 1: EGD With Cap First, Followed by EGD Without Cap	Arm 2: EGD Without Cap First, Followed by EGD With Cap
Arm/Group Description	-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap.	-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap
Measure Participants	50	50
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Adverse events were collected from start of EGD until 48 hours after EGD.
Adverse Event Reporting Description	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).
Arm/Group Title	Arm 1: EGD With Cap First, Followed by EGD Without Cap		Arm 2: EGD Without Cap First, Followed by EGD With Cap
Arm/Group Description	-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap.		-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap
All Cause Mortality
	Arm 1: EGD With Cap First, Followed by EGD Without Cap		Arm 2: EGD Without Cap First, Followed by EGD With Cap
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Serious Adverse Events
	Arm 1: EGD With Cap First, Followed by EGD Without Cap		Arm 2: EGD Without Cap First, Followed by EGD With Cap
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)
Other (Not Including Serious) Adverse Events
	Arm 1: EGD With Cap First, Followed by EGD Without Cap		Arm 2: EGD Without Cap First, Followed by EGD With Cap
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/50 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.