Sessile Serrated Adenoma
Conditions
Brief summary
This study evaluates whether the use of a disposable colonoscope attachment, Endocuff Vision, can increase the detection of sessile serrated adenomas. Participating patients will be randomized to receive either standard colonoscopy or colonoscopy with the Endocuff Vision.
Detailed description
Colon cancer remains the second leading cause of death amongst both men and women in the United States(1). With the advent of screening colonoscopy, mortality from colorectal cancer has decreased, and colonoscopy is the current gold standard for colorectal cancer screening and prevention by removing adenomatous polyps. Different devices have been employed to assist the endoscopist in the detection of colon adenomas, as these lesions serve as precursors to colon neoplasia. One device of interest is the Endocuff Vision. The Endocuff Vision is a disposable device with a single row of soft, hair-like projections that aid in flattening colonic folds during colonoscope withdrawal to increase the detection of colon adenomas. Previous studies have compared endocuff-assisted colonoscopy to standard colonoscopy, and the results have indicated significant improvement in overall adenoma detection rates (ADR)(2-4). All of these studies have focused on the detection of conventional tubular adenomas as primary endpoints. However, there exists an additional serrated adenoma pathway that may give rise to about 15-20% of colon cancers (5). These lesions tend to be flatter with subtler features that make them harder to detect. A recent meta-analysis suggested that the endocuff was more effective at detecting sessile serrated adenomas compared to standard colonoscopy; however, these findings are derived from secondary data analyses (6). To the best of our knowledge, no study to date has examined the sessile serrated adenoma detection rate as a primary endpoint. Our previous study examined the differences in overall adenoma detection between endocuff-assisted and standard colonoscopy. Although there was no statistical difference in ADR between endocuff-assisted colonoscopy and standard colonoscopy, investigators did observe a numeric difference in sessile serrated adenoma detection rate (SSADR), 16.7% vs 23.8% (p = 0.5) between standard colonoscopy and endocuff-assisted colonoscopy, respectively. Given the previous sample size was calculated to detect differences in overall ADR, the study was not powered to determine whether this observed difference in SSADR was significant. Therefore, the goal of the proposed study is to compare standard colonoscopy to endocuff-assisted colonoscopy in patients undergoing colonoscopy for colon cancer screening to determine differences in sessile serrated adenoma detection rates.
Interventions
DEVICEEndocuff Vision Assisted Colonoscopy
Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
Sponsors
University of California, Davis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Intervention model description
Participants will be enrolled to receive either conventional colonoscopy or colonoscopy with addition of Endocuff Vision device.
Eligibility
Sex/Gender
ALL
Age
45 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* All patients who present to our outpatient gastroenterology suites for screening colonoscopy.
Exclusion criteria
* Age less than 45 and greater than 85 * Prior history of colon polyps (hyperplastic polyp, tubular adenoma or sessile serrated adenoma) and colon cancer * Patients with inflammatory bowel disease * Patients suspected to have colon cancer based on non-invasive tests such as stool tests for hemoglobin or DNA, or imaging finding suggestive of colon cancer (CT or barium enema). * Patients undergoing colonoscopy for evaluation of symptoms such as abdominal pain, rectal bleeding, diarrhea, constipation, etc., or patient with iron deficiency anemia suspected to be due to ongoing bleeding inside the colon * Patients with family history of colon cancer in 1st degree relative below the age of 60 * Patients with family history of hereditary polyposis syndromes such as Lynch syndrome, familial adenomatous polyposis etc., which are associated with an increased risk of colon cancer * Patients unable to consent * Pregnant patients * Incarcerated patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sessile Serrated Adenomas | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. | Number of colonoscopies with at least one sessile serrated adenoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proximal Colon Adenomas | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. | Number of colonoscopies with at least one sessile serrated adenoma or conventional adenoma |
| Adenomas Per Colonoscopy | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. | Total adenomas detected in each treatment arm divided amongst the number of patients in each arm |
| Sessile Serrated Adenomas Per Colonoscopy | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. | Total sessile serrated adenomas in each treatment arm divided amongst the number of patients in each arm. |
| Adenoma Detection | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. | Number of colonoscopies with at least one adenoma |
| Sessile Serrated Adenomas (SSA) Per Positive Colonoscopy | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. | The total sessile serrated adenomas detected divided by the number of colonoscopies with at least one sessile serrated adenoma |
| Colonoscope Withdrawal Time | Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion. | The time it takes to withdraw the colonoscope from the cecum to the end of the examination. |
| Differences in Quality of Bowel Preparation | Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion. | Measurement of colon preparation based on the validated Boston Bowel Prep Score. Each colon segment (right, transverse, and left colons) will receive a score of 0 (worse) to 3 (best). The sum of each segment will be reported as a total score of 0 (worse) to 9 (best). |
| Adenomas Per Positive Colonoscopy | Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion. | The total adenomas detected divided by the number of colonoscopies with at least one adenoma |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Colonoscopy Patients randomly assigned to this group will receive standard colonoscopy without the use of a distal attachment. | 216 |
| Endocuff Vision Assisted Colonoscopy Patients randomly assigned to this group will receive colonoscopy with the use of the Endocuff Vision distal attachment.
Endocuff Vision Assisted Colonoscopy: Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps. | 211 |
| Total | 427 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Colonoscopy | Endocuff Vision Assisted Colonoscopy | Total |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 7.2 | 57.9 years STANDARD_DEVIATION 7.7 | 57.6 years STANDARD_DEVIATION 7.5 |
| Alcohol consumption No | 63 Participants | 66 Participants | 129 Participants |
| Alcohol consumption Yes | 153 Participants | 145 Participants | 298 Participants |
| Body Mass Index (BMI) | 27.7 kg/m2 STANDARD_DEVIATION 4.9 | 27.6 kg/m2 STANDARD_DEVIATION 4.6 | 27.7 kg/m2 STANDARD_DEVIATION 4.8 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 114 Participants | 92 Participants | 206 Participants |
| Sex: Female, Male Male | 102 Participants | 119 Participants | 221 Participants |
| Smoking Current | 10 Participants | 6 Participants | 16 Participants |
| Smoking Former | 55 Participants | 50 Participants | 105 Participants |
| Smoking Never | 151 Participants | 155 Participants | 306 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 216 | 0 / 211 |
| other Total, other adverse events | 0 / 216 | 0 / 211 |
| serious Total, serious adverse events | 0 / 216 | 0 / 211 |
Outcome results
Primary
Sessile Serrated Adenomas
Number of colonoscopies with at least one sessile serrated adenoma
Time frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.
Population: Participants with complete colonoscopy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Colonoscopy | Sessile Serrated Adenomas | 42 colonoscopies |
| Endocuff Vision Assisted Colonoscopy | Sessile Serrated Adenomas | 59 colonoscopies |
Secondary
Adenoma Detection
Number of colonoscopies with at least one adenoma
Time frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.
Population: Participants with complete colonoscopy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Colonoscopy | Adenoma Detection | 159 colonoscopies |
| Endocuff Vision Assisted Colonoscopy | Adenoma Detection | 199 colonoscopies |
Secondary
Adenomas Per Colonoscopy
Total adenomas detected in each treatment arm divided amongst the number of patients in each arm
Time frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Colonoscopy | Adenomas Per Colonoscopy | 0.96 adenomas per participant | Standard Deviation 1.33 |
| Endocuff Vision Assisted Colonoscopy | Adenomas Per Colonoscopy | 1.24 adenomas per participant | Standard Deviation 1.67 |
Secondary
Adenomas Per Positive Colonoscopy
The total adenomas detected divided by the number of colonoscopies with at least one adenoma
Time frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Colonoscopy | Adenomas Per Positive Colonoscopy | 1.97 Adenomas Per Positive Colonoscopy | Standard Deviation 1.27 |
| Endocuff Vision Assisted Colonoscopy | Adenomas Per Positive Colonoscopy | 2.12 Adenomas Per Positive Colonoscopy | Standard Deviation 1.71 |
Secondary
Colonoscope Withdrawal Time
The time it takes to withdraw the colonoscope from the cecum to the end of the examination.
Time frame: Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Colonoscopy | Colonoscope Withdrawal Time | 14.74 minutes | Standard Deviation 0.28 |
| Endocuff Vision Assisted Colonoscopy | Colonoscope Withdrawal Time | 15.01 minutes | Standard Deviation 0.31 |
Secondary
Differences in Quality of Bowel Preparation
Measurement of colon preparation based on the validated Boston Bowel Prep Score. Each colon segment (right, transverse, and left colons) will receive a score of 0 (worse) to 3 (best). The sum of each segment will be reported as a total score of 0 (worse) to 9 (best).
Time frame: Time point of assessment will be recorded at the time of colonoscopy. This data will be collected through study completion, analyzed and reported up to 6 months after study completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Colonoscopy | Differences in Quality of Bowel Preparation | 8.7 score on a scale (0 to 9) | Standard Deviation 0.8 |
| Endocuff Vision Assisted Colonoscopy | Differences in Quality of Bowel Preparation | 8.7 score on a scale (0 to 9) | Standard Deviation 0.9 |
Secondary
Proximal Colon Adenomas
Number of colonoscopies with at least one sessile serrated adenoma or conventional adenoma
Time frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Colonoscopy | Proximal Colon Adenomas | 83 colonoscopies |
| Endocuff Vision Assisted Colonoscopy | Proximal Colon Adenomas | 99 colonoscopies |
Secondary
Sessile Serrated Adenomas Per Colonoscopy
Total sessile serrated adenomas in each treatment arm divided amongst the number of patients in each arm.
Time frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Colonoscopy | Sessile Serrated Adenomas Per Colonoscopy | 0.27 Sessile Serrated Adenomas Per Participan | Standard Deviation 0.59 |
| Endocuff Vision Assisted Colonoscopy | Sessile Serrated Adenomas Per Colonoscopy | 0.35 Sessile Serrated Adenomas Per Participan | Standard Deviation 0.74 |
Secondary
Sessile Serrated Adenomas (SSA) Per Positive Colonoscopy
The total sessile serrated adenomas detected divided by the number of colonoscopies with at least one sessile serrated adenoma
Time frame: Time point of assessment will be when pathology results are made available 2 weeks after procedure. Data will be collected through study completion, analyzed and reported up to 6 months after study completion.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Colonoscopy | Sessile Serrated Adenomas (SSA) Per Positive Colonoscopy | 1.20 SSA Per Positive Colonoscopy | Standard Deviation 0.63 |
| Endocuff Vision Assisted Colonoscopy | Sessile Serrated Adenomas (SSA) Per Positive Colonoscopy | 1.48 SSA Per Positive Colonoscopy | Standard Deviation 0.82 |