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| Name | Class |
|---|---|
| Kansas City Veteran Affairs Medical Center | FED |
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The investigators hypothesize that high definition colonoscopy with close focus narrow band imaging features has a high diagnostic accuracy for colorectal polyp histology, and can replace formal pathologic assessment in cases of high diagnostic confidence.
A recent single arm prospective cohort study suggested that high definition colonoscopy with narrow band imaging is an acceptable strategy to diagnose polyp histology and determine future surveillance intervals. Endoscopic proficiency in macroscopic features to differentiate polyp histology can be attained in a relatively short time period. A new high definition colonoscope with close focus narrow band imaging features may further improve diagnostic accuracy for polyp differentiation, and can replace formal pathologic assessment in cases of high diagnostic confidence.
Primary Aim: Compare the diagnostic accuracy of high definition narrow band imaging colonoscopy with and without close focus features for the macroscopic differentiation of neoplastic and non-neoplastic colorectal lesions using histopathologic diagnosis as the reference standard.
Secondary Aims: Compare diagnostic characteristics of the colonoscopes, measure concordance of high confidence and accuracy, compare accuracy of predicted versus actual surveillance interval recommendations, perform a cost-effective analysis of endoscopic versus pathologic diagnoses, and measure complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Close focus HD NBI Colonoscopy System | Experimental | Use of close focus to make optical diagnosis |
|
| Current HD NBI Colonoscopy System | No Intervention | Use of standard focus for optical diagnosis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Close focus HD NBI Colonoscopy System | Device | Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups. | Measure of the percentage of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without close focus features. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology Note: one patient may have multiple polyps. | At the time of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | Measure the cost of colonoscopy with macroscopic histopathologic diagnosis of colorectal lesions compared to colonoscopy with conventional microscopic histopathologic diagnosis, on the lesions that were managed based on an accurate endoscopic diagnosis. A reduction in pathology specimens may improve the efficiency of the procedure and has direct pathology cost savings (as well as indirect savings, which were not measured). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonya Kaltenbach, MD MS | Veterans Affairs Palo Alto | Principal Investigator |
| Roy Soetikno, MD MS | Veterans Affairs Palo Alto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Palo Alto | Palo Alto | California | 94304 | United States | ||
| Veterans Affairs Kansas City |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18061178 | Background | Kaltenbach T, Sano Y, Friedland S, Soetikno R; American Gastroenterological Association. American Gastroenterological Association (AGA) Institute technology assessment on image-enhanced endoscopy. Gastroenterology. 2008 Jan;134(1):327-40. doi: 10.1053/j.gastro.2007.10.062. Epub 2007 Oct 30. | |
| 16012987 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Close Focus HD NBI Colonoscopy System | Use of close focus to make optical diagnosis Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth. |
| FG001 | Current HD NBI Colonoscopy System | Use of standard focus for optical diagnosis |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Close Focus HD NBI Colonoscopy System | Use of close focus to make optical diagnosis Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth. |
| BG001 | Current HD NBI Colonoscopy System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups. | Measure of the percentage of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without close focus features. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology Note: one patient may have multiple polyps. | We analyzed all diminutive sized polyps to assess the number of polyps that endoscopists were able to make an accurate high confidence optical diagnosis. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (non-neoplasia) in the NICE classification and no features associated with the other histology. | Posted | Number | 95% Confidence Interval | Percent of accurate HC predictions | At the time of procedure | Polyps analyzed | Polyps analyzed |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Close Focus HD NBI Colonoscopy System | Use of close focus to make optical diagnosis Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tonya Kaltenbach | San Francisco VA Medical Center | 415-221-4810 | 94121 | tonya.kaltenbach@va.gov |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| At the time of procedure |
| Diagnostic Characteristics | Compare the diagnostic characteristics (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without close focus features. Accuracy: number of endoscopic predictions of adenomatous polyps histologically confirmed to be adenomatous/number of predicted hyperplastic polyps confirmed to be hyperplastic out of all polyps Sensitivity: number of endoscopic predictions (optical diagnosis) of adenomatous (neoplastic) polyps out of all histologically confirmed polyps Specificity: number of endoscopic predictions of hyperplastic (non-neoplastic) polyps out of all histologically confirmed polyps PPV: number of histologically confirmed adenomatous polyps out of all endoscopic predictions of adenomatous polyps NPV: number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps Note: a patient may have multiple polyps | At time of procedure |
| Accuracy of Predicted Versus Actual Surveillance Intervals | Compared the accuracy of predicted versus actual surveillance colonoscopy interval recommendations by determining number of patients with correct surveillance interval recommendation. | At the time of procedure |
| Learning Curve | Examine the impact of a learning curve (i.e. NPV of high confidence at each of endoscopist's first 50% of exams versus last 50% exams to endoscopically predict polyp histology). NPV is defined as "number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps. | At time of procedure. |
| Kansas City |
| Missouri |
| 64128 |
| United States |
| Muto M, Katada C, Sano Y, Yoshida S. Narrow band imaging: a new diagnostic approach to visualize angiogenesis in superficial neoplasia. Clin Gastroenterol Hepatol. 2005 Jul;3(7 Suppl 1):S16-20. doi: 10.1016/s1542-3565(05)00262-4. |
| 19187781 | Background | Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10. |
| 20561618 | Background | Raghavendra M, Hewett DG, Rex DK. Differentiating adenomas from hyperplastic colorectal polyps: narrow-band imaging can be learned in 20 minutes. Gastrointest Endosc. 2010 Sep;72(3):572-6. doi: 10.1016/j.gie.2010.03.1124. Epub 2010 Jun 19. |
| 19584829 | Background | Rastogi A, Keighley J, Singh V, Callahan P, Bansal A, Wani S, Sharma P. High accuracy of narrow band imaging without magnification for the real-time characterization of polyp histology and its comparison with high-definition white light colonoscopy: a prospective study. Am J Gastroenterol. 2009 Oct;104(10):2422-30. doi: 10.1038/ajg.2009.403. Epub 2009 Jul 7. |
| 19910250 | Background | Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10. |
| 19922926 | Background | Rex DK, Fennerty MB, Sharma P, Kaltenbach T, Soetikno R. Bringing new endoscopic imaging technology into everyday practice: what is the role of professional GI societies? Polyp imaging as a template for moving endoscopic innovation forward to answer key clinical questions. Gastrointest Endosc. 2010 Jan;71(1):142-6. doi: 10.1016/j.gie.2009.09.011. Epub 2009 Nov 17. No abstract available. |
| 29174789 | Derived | von Renteln D, Kaltenbach T, Rastogi A, Anderson JC, Rosch T, Soetikno R, Pohl H. Simplifying Resect and Discard Strategies for Real-Time Assessment of Diminutive Colorectal Polyps. Clin Gastroenterol Hepatol. 2018 May;16(5):706-714. doi: 10.1016/j.cgh.2017.11.036. Epub 2017 Nov 23. |
| 25387891 | Derived | Kaltenbach T, Rastogi A, Rouse RV, McQuaid KR, Sato T, Bansal A, Kosek JC, Soetikno R. Real-time optical diagnosis for diminutive colorectal polyps using narrow-band imaging: the VALID randomised clinical trial. Gut. 2015 Oct;64(10):1569-77. doi: 10.1136/gutjnl-2014-307742. Epub 2014 Nov 11. |
| 25264764 | Derived | McGill SK, Soetikno R, Rastogi A, Rouse RV, Sato T, Bansal A, McQuaid K, Kaltenbach T. Endoscopists can sustain high performance for the optical diagnosis of colorectal polyps following standardized and continued training. Endoscopy. 2015 Mar;47(3):200-6. doi: 10.1055/s-0034-1378096. Epub 2014 Sep 29. |
Use of standard focus for optical diagnosis |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Indication | Count of Participants | Participants |
|
| OG000 |
| Close Focus HD NBI Colonoscopy System |
Use of close focus to make optical diagnosis Close focus HD NBI Colonoscopy System: Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth. |
| OG001 | Current HD NBI Colonoscopy System | Use of standard focus for optical diagnosis |
|
|
| Secondary | Cost | Measure the cost of colonoscopy with macroscopic histopathologic diagnosis of colorectal lesions compared to colonoscopy with conventional microscopic histopathologic diagnosis, on the lesions that were managed based on an accurate endoscopic diagnosis. A reduction in pathology specimens may improve the efficiency of the procedure and has direct pathology cost savings (as well as indirect savings, which were not measured). | Posted | Number | Specimen bottles that could be omitted | At the time of procedure |
|
|
|
| Secondary | Diagnostic Characteristics | Compare the diagnostic characteristics (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without close focus features. Accuracy: number of endoscopic predictions of adenomatous polyps histologically confirmed to be adenomatous/number of predicted hyperplastic polyps confirmed to be hyperplastic out of all polyps Sensitivity: number of endoscopic predictions (optical diagnosis) of adenomatous (neoplastic) polyps out of all histologically confirmed polyps Specificity: number of endoscopic predictions of hyperplastic (non-neoplastic) polyps out of all histologically confirmed polyps PPV: number of histologically confirmed adenomatous polyps out of all endoscopic predictions of adenomatous polyps NPV: number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps Note: a patient may have multiple polyps | 975 total polyps were found with high confidence predictions made on 774 of them.We assessed diagnostic performance of the high confidence predictions. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology. | Posted | Number | 95% Confidence Interval | percentage of high confidence prediction | At time of procedure | Polyps analyzed | Polyps analyzed |
|
|
|
| Secondary | Accuracy of Predicted Versus Actual Surveillance Intervals | Compared the accuracy of predicted versus actual surveillance colonoscopy interval recommendations by determining number of patients with correct surveillance interval recommendation. | Posted | Count of Participants | Participants | At the time of procedure |
|
|
|
| Secondary | Learning Curve | Examine the impact of a learning curve (i.e. NPV of high confidence at each of endoscopist's first 50% of exams versus last 50% exams to endoscopically predict polyp histology). NPV is defined as "number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps. | 975 total polyps were found and we were able to make high confidence predictions on 774 of them. | Posted | Number | 95% Confidence Interval | percentage of high confidence prediction | At time of procedure. | Diminutive polyps | Diminutive polyps |
|
|
|
| Post-Hoc | Surveillance Colonoscopy Advanced Pathology Findings | Compare the advanced pathology and colon cancer incidence at surveillance colonoscopy of the groups who underwent high definition narrow band imaging colonoscopy with and without close focus features, and more specifically who underwent macroscopic versus microscopic polyp management. This applies if we bring the patient back after 5 years, we have not collected the data yet. | Not Posted | 5 to 10 years after colonoscopy | Participants |
| 0 |
| 277 |
| 0 |
| 277 |
| EG001 | Current HD NBI Colonoscopy System | Use of standard focus for optical diagnosis | 0 | 281 | 0 | 281 |
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| 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 |
| Specificity |
|
| PPV |
|
| NPV |
|