Colonic Polyps, Colorectal Cancer, Colorectal Neoplasms
Conditions
Keywords
Colonoscopy, Diagnostic imaging, Colorectal Neoplasm, Tandem Colonoscopy, Flat Polyp, Nonpolypoid, Flat and Depressed Lesions, Primary Prevention, Endoscopy
Brief summary
We hypothesize that high definition narrow band imaging (NBI) colonoscopy compared to high definition white light colonoscopy will detect an increased number of nonpolypoid (flat and depressed) colorectal neoplasm.
Detailed description
Interval colorectal cancers diagnosed within a three year period following a clearing colonoscopy have been reported at a rate of 1 cancer/1000 person years.The majority of these cancers are likely a consequence of a missed neoplastic lesion during routine colonoscopy. Recent tandem colonoscopy studies have shown no significant difference in adenoma miss or detection rates using narrow band imaging as compared to colonoscopy using white light. However, higher detection of flat neoplastic lesions using NBI was shown in a meta-analysis and should be furthered studied, especially considering that they are thought to be a strong contributor to a false negative colonoscopy.
Interventions
DEVICEOlympus Colonoscope CFHQ190AL
Technically improved colonoscope with close focus high definition narrow band imaging.
Sponsors
Kansas City Veteran Affairs Medical Center
VA Palo Alto Health Care System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adult patients referred for routine colonoscopy are eligible
Exclusion criteria
* Known Inflammatory bowel disease * Referred for endoscopic evaluation and removal of colorectal lesion * Personal or family history of polyposis or non-polyposis syndrome * Presentation for emergency endoscopy * Inability to remove polyp due to coagulopathy or thrombocytopenia * Inability to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) | Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Missed Lesions on Index Colonoscopy. | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) | Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings. |
| Percentage of Nonpolypoid (Flat) Missed Lesions | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) | Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High Definition NBI Colonoscopy Use of high definition narrow band imaging colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging. | 128 |
| High Definition White Light Colonoscopy Use of high definition white light colonoscopy during examination for polyp detection.
Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging. | 143 |
| Total | 271 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patients did not complete tandem. | 4 | 6 |
Baseline characteristics
| Characteristic | High Definition NBI Colonoscopy | High Definition White Light Colonoscopy | Total |
|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 9.4 | 62.3 years STANDARD_DEVIATION 8.6 | 63 years STANDARD_DEVIATION 9.01 |
| Sex: Female, Male Female | 3 Participants | 8 Participants | 11 Participants |
| Sex: Female, Male Male | 125 Participants | 135 Participants | 260 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 128 | 0 / 143 |
| serious Total, serious adverse events | 0 / 128 | 0 / 143 |
Outcome results
Primary
Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm
Compare the nonpolypoid colorectal neoplasm detection characteristics of the new high definition narrow band imaging colonoscopy to conventional high definition white light mode colonoscopy.
Time frame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| High Definition NBI Colonoscopy | Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm | 33 Participants |
| High Definition White Light Colonoscopy | Number of Participants With Nonpolypoid (Flat and Depressed) Colorectal Neoplasm | 43 Participants |
Secondary
Percentage of Missed Lesions on Index Colonoscopy.
Compare the number of missed lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy, based on the tandem colonoscopy findings.
Time frame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Definition NBI Colonoscopy | Percentage of Missed Lesions on Index Colonoscopy. | 32.0 percentage of adenomas |
| High Definition White Light Colonoscopy | Percentage of Missed Lesions on Index Colonoscopy. | 31.4 percentage of adenomas |
p-value: 0.21Chi-squared
Secondary
Percentage of Nonpolypoid (Flat) Missed Lesions
Compare the number of missed non-polypoid lesions on the index examination using the new high definition narrow band imaging colonoscopy to the conventional high definition white light mode colonoscopy.
Time frame: One week (time of procedure plus time for pathology of polyp to be analyzed by histology)
Population: Adenoma by shape (i.e. Flat)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| High Definition NBI Colonoscopy | Percentage of Nonpolypoid (Flat) Missed Lesions | 7.2 percentage of adenomas |
| High Definition White Light Colonoscopy | Percentage of Nonpolypoid (Flat) Missed Lesions | 11.8 percentage of adenomas |
p-value: 0.18Chi-squared