Barrett Esophagus
Conditions
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.
Interventions
PROCEDUREEsophagogastroduodenoscopy 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.
DEVICEOlympus Disposable Distal Attachment Cap
-The second endoscopist will be blinded to the results of the initial exam.
Sponsors
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap | At the time of procedure (day 1) | — |
| Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma | At the time of procedure (day 1) | — |
| Total Procedure Duration in Seconds | At the time of procedure (day 1) | — |
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 50 |
| 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. | 50 |
| Total | 100 |
Baseline characteristics
| Characteristic | Arm 1: EGD With Cap First, Followed by EGD Without Cap | Total | Arm 2: EGD Without Cap First, Followed by EGD With Cap |
|---|---|---|---|
| Age, Continuous | 65.5 years | 66 years | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 99 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 49 Participants | 99 Participants | 50 Participants |
| Region of Enrollment United States | 50 participants | 100 participants | 50 participants |
| Sex: Female, Male Female | 7 Participants | 15 Participants | 8 Participants |
| Sex: Female, Male Male | 43 Participants | 85 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 50 |
| other Total, other adverse events | 0 / 50 | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 | 0 / 50 |
Outcome results
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
Time frame: At the time of procedure (day 1)
Population: Participants had to have visible lesions to be evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EGD Without CAP | Number of Participants Who Had a Diagnostic Yield Obtained | 56 Participants |
| EGD With CAP | Number of Participants Who Had a Diagnostic Yield Obtained | 60 Participants |
Secondary
Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma
Time frame: At the time of procedure (day 1)
Population: Out of the 100 enrolled participants, there were 2 participants with missing pathology reports.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EGD Without CAP | Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma | 22 Participants |
| EGD With CAP | Number of Participants With High Grade Dysplasia or Esophageal Adenocarcinoma | 23 Participants |
Secondary
Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap
Time frame: At the time of procedure (day 1)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EGD Without CAP | Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap | 56 Participants |
| EGD With CAP | Number of Participants With Visible Lesions in EGD With Cap Versus Without Cap | 60 Participants |
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).
Time frame: Through 48 hours after EGD
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EGD Without CAP | Safety as Measured by Number of Participants With Procedure-related Adverse Events | 0 Participants |
| EGD With CAP | Safety as Measured by Number of Participants With Procedure-related Adverse Events | 0 Participants |
Secondary
Total Procedure Duration in Seconds
Time frame: At the time of procedure (day 1)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EGD Without CAP | Total Procedure Duration in Seconds | 160.9 seconds | Standard Deviation 74.6 |
| EGD With CAP | Total Procedure Duration in Seconds | 159.8 seconds | Standard Deviation 73.4 |