Clinical Study of Real Time Colorectal Polyp Diagnosis During Colonoscopy - the VALID Colonoscopy Study



Status:Completed
Conditions:Colorectal Cancer, Cancer, Gastrointestinal
Therapuetic Areas:Gastroenterology, Oncology
Healthy:No
Age Range:18 - Any
Updated:6/3/2018
Start Date:March 2011
End Date:October 2015

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Real Time Colorectal Polyp Diagnosis in Colorectal Cancer Screening Using Close Focus High Definition Narrow Band Imaging Colonoscopy Compared to Conventional Histopathology Diagnosis - the VALID (Veterans Affairs Lesion Interpretation and Diagnosis) Colonoscopy Study

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.

Inclusion Criteria:

- Adult patients referred for routine colonoscopy

Exclusion Criteria:

- Known inflammatory bowel disease

- 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
We found this trial at
2
sites
Kansas City, Missouri 64128
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Kansas City, MO
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Palo Alto, California 94304
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Palo Alto, CA
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