Colorectal Adenomatous Polyps
Conditions
Brief summary
This study is a randomized controlled trial to determine whether i-scan can improve the detection of conventional adenomas and sessile serrated adenomas/polyps.
Detailed description
This is a randomized controlled trial comparing the use of i-scan (digital surface and contrast enhancement of the mucosa) versus standard high-definition white light for the detection of conventional adenomas and sessile serrated adenomas/polyps. Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as sessile serrated adenomas/polyps (SSA) are located primarily proximal to the splenic flexure. Sessile serrated adenomas/polyps share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Recent studies have shown that image enhanced endoscopy can highlight the appearance of these lesions. This study will test whether i-scan increases the detection of conventional adenomas and sessile serrated adenomas/polyps in a randomized controlled trial.
Interventions
DEVICEi-scan
examination will be performed with i-scan digital enhancement
DEVICEstandard high-definition white light
examination will be performed with high-definition white light
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 50-75 * Intact colon and rectum * Willing to sign an informed consent form
Exclusion criteria
* Subjects less than 50 years of age or greater than 75 years of age * Subjects who are in the inpatient unit * Subjects with diverticulitis, * Subjects with inflammatory bowel disease * Subjects with polyposis syndromes * Subjects with previous surgical resection of any portion of the colon or rectum * Subjects referred for endoscopic resection of previously diagnosed colorectal polyp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants With Conventional Adenoma Detected | 12 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| I-scan Inspection with i-scan surface enhancement
i-scan: examination will be performed with i-scan digital enhancement | 369 |
| Standard High-definition White Light Inspection with standard high-definition white light (usual care)
standard high-definition white light: examination will be performed with high-definition white light | 371 |
| Total | 740 |
Baseline characteristics
| Characteristic | I-scan | Standard High-definition White Light | Total |
|---|---|---|---|
| Age, Continuous | 61.4 years STANDARD_DEVIATION 7.5 | 60.8 years STANDARD_DEVIATION 7.5 | 61.1 years STANDARD_DEVIATION 7.5 |
| body mass index | 27.0 kg/m^2 STANDARD_DEVIATION 5.7 | 26.5 kg/m^2 STANDARD_DEVIATION 4.9 | 26.7 kg/m^2 STANDARD_DEVIATION 5.2 |
| 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 | 0 Participants | 0 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 | 369 Participants | 371 Participants | 740 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 369 participants | 371 participants | 740 participants |
| Sex: Female, Male Female | 185 Participants | 187 Participants | 372 Participants |
| Sex: Female, Male Male | 184 Participants | 184 Participants | 368 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 369 | 0 / 371 |
| other Total, other adverse events | 0 / 369 | 0 / 371 |
| serious Total, serious adverse events | 0 / 369 | 0 / 371 |
Outcome results
Primary
Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (I-scan) | Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected | 208 Participants |
| Control (HDWL) | Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected | 171 Participants |
Secondary
Number of Participants With Conventional Adenoma Detected
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention (I-scan) | Number of Participants With Conventional Adenoma Detected | 174 Participants |
| Control (HDWL) | Number of Participants With Conventional Adenoma Detected | 140 Participants |