Trial Outcomes & Findings for 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 (NCT NCT03417570)
NCT ID: NCT03417570
Last Updated: 2022-09-01
Results Overview
-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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
At the time of procedure (day 1)
Results posted on
2022-09-01
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
50
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Arm 1: EGD With Cap First, Followed by EGD Without Cap
n=50 Participants
-Participants in the first arm will undergo EGD with cap first, followed by EGD without cap in the same procedural period.
|
Arm 2: EGD Without Cap First, Followed by EGD With Cap
n=50 Participants
-Participants in the second arm will undergo EGD without cap first, followed by EGD with cap in the same procedural period.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
n=5 Participants
|
66 years
n=7 Participants
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
49 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of procedure (day 1)Population: Participants had to have visible lesions to be evaluable for this outcome measure.
-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
Outcome measures
| Measure |
EGD Without CAP
n=56 Participants
-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
EGD With CAP
n=60 Participants
-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
|---|---|---|
|
Number of Participants Who Had a Diagnostic Yield Obtained
|
56 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: At the time of procedure (day 1)Outcome measures
| Measure |
EGD Without CAP
n=100 Participants
-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
EGD With CAP
n=100 Participants
-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
|---|---|---|
|
Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap
|
56 Participants
|
60 Participants
|
SECONDARY outcome
Timeframe: At the time of procedure (day 1)Population: Out of the 100 enrolled participants, there were 2 participants with missing pathology reports.
Outcome measures
| Measure |
EGD Without CAP
n=98 Participants
-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
EGD With CAP
n=98 Participants
-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
|---|---|---|
|
Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma
|
22 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: At the time of procedure (day 1)Outcome measures
| Measure |
EGD Without CAP
n=100 Participants
-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
EGD With CAP
n=100 Participants
-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
|---|---|---|
|
Total Procedure Duration in Seconds
|
160.9 seconds
Standard Deviation 74.6
|
159.8 seconds
Standard Deviation 73.4
|
SECONDARY outcome
Timeframe: 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).
Outcome measures
| Measure |
EGD Without CAP
n=50 Participants
-Esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
EGD With CAP
n=50 Participants
-Cap-assisted esophagogastroduodenoscopy (EGD) with high-definition-white light endoscopy (HD-WLE) and narrow band imaging (NBI)
|
|---|---|---|
|
Safety as Measured by Number of Participants With Procedure-related Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Arm 1: EGD With Cap First, Followed by EGD Without Cap
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2: EGD Without Cap First, Followed by EGD With Cap
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vladimir M. Kushnir, M.D.
Washington University School of Medicine
Phone: 314-454-5960
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place