Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study
NCT ID: NCT01288833
Last Updated: 2018-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
NA
558 participants
INTERVENTIONAL
2011-03-31
2015-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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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.
Current HD NBI Colonoscopy System
Use of standard focus for optical diagnosis
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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Kansas City Veteran Affairs Medical Center
FED
VA Palo Alto Health Care System
FED
Responsible Party
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Roy Soetikno
Co-Principal Investigator
Principal Investigators
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Tonya Kaltenbach, MD MS
Role: PRINCIPAL_INVESTIGATOR
Veterans Affairs Palo Alto
Roy Soetikno, MD MS
Role: PRINCIPAL_INVESTIGATOR
Veterans Affairs Palo Alto
Locations
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Veterans Affairs Palo Alto
Palo Alto, California, United States
Veterans Affairs Kansas City
Kansas City, Missouri, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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VALID PA19624
Identifier Type: -
Identifier Source: org_study_id
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