Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kansas City Veteran Affairs Medical Center | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Definition NBI Colonoscopy | Experimental | Use of high definition narrow band imaging colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging. |
|
| High Definition White Light Colonoscopy | Placebo Comparator | Use of high definition white light colonoscopy during examination for polyp detection. The same intervention is used on both arms: the Olympus Colonoscope CFHQ190AL, a technically improved colonoscope with close focus high definition narrow band imaging. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olympus Colonoscope CFHQ190AL | Device | Technically improved colonoscope with close focus high definition narrow band imaging. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tonya Kaltenbach, MD MS | San Francisco Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Palo Alto | Palo Alto | California | 94304 | United States | ||
| Veterans Affairs San Francisco |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18319413 | Background | Soetikno RM, Kaltenbach T, Rouse RV, Park W, Maheshwari A, Sato T, Matsui S, Friedland S. Prevalence of nonpolypoid (flat and depressed) colorectal neoplasms in asymptomatic and symptomatic adults. JAMA. 2008 Mar 5;299(9):1027-35. doi: 10.1001/jama.299.9.1027. | |
| 18523025 | Background | Kaltenbach T, Friedland S, Soetikno R. A randomised tandem colonoscopy trial of narrow band imaging versus white light examination to compare neoplasia miss rates. Gut. 2008 Oct;57(10):1406-12. doi: 10.1136/gut.2007.137984. Epub 2008 Jun 3. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | High Definition White Light Colonoscopy |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) |
| San Francisco |
| California |
| 94121 |
| United States |
| Veterans Affairs Kansas City | Kansas City | Missouri | 64128 | United States |
| 20656245 | Background | Kaltenbach T, Soetikno R. Image-enhanced endoscopy is critical in the detection, diagnosis, and treatment of non-polypoid colorectal neoplasms. Gastrointest Endosc Clin N Am. 2010 Jul;20(3):471-85. doi: 10.1016/j.giec.2010.04.001. |
| 11316211 | Background | Rex DK, Bond JH, Feld AD. Medical-legal risks of incident cancers after clearing colonoscopy. Am J Gastroenterol. 2001 Apr;96(4):952-7. doi: 10.1111/j.1572-0241.2001.03677.x. |
| 17631129 | Background | Rex DK, Helbig CC. High yields of small and flat adenomas with high-definition colonoscopes using either white light or narrow band imaging. Gastroenterology. 2007 Jul;133(1):42-7. doi: 10.1053/j.gastro.2007.04.029. Epub 2007 Apr 20. |
| 19111693 | Background | van den Broek FJ, Reitsma JB, Curvers WL, Fockens P, Dekker E. Systematic review of narrow-band imaging for the detection and differentiation of neoplastic and nonneoplastic lesions in the colon (with videos). Gastrointest Endosc. 2009 Jan;69(1):124-35. doi: 10.1016/j.gie.2008.09.040. No abstract available. |
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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) |
|
|
| ||||||||||||||||||||||||||||||
| 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. | Posted | Number | percentage of adenomas | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) |
| ||||||||||||||||||||||||||||||||
| 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. | Adenoma by shape (i.e. Flat) | Posted | Number | percentage of adenomas | One week (time of procedure plus time for pathology of polyp to be analyzed by histology) |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 128 | 0 | 128 | ||
| EG001 | 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. | 0 | 143 | 0 | 143 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tonya Kaltenbach | San Francisco VA Medical Center | 415-221-4810 | 94121 | tonya.kaltenbach@va.gov |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| Male |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| Units | Counts |
|---|
| Participants |
|
|
|