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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Neoplasm
- Sponsor
- VA Palo Alto Health Care System
- Enrollment
- 558
- Locations
- 2
- Primary Endpoint
- Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Roy Soetikno
Co-Principal Investigator
VA Palo Alto Health Care System
Eligibility Criteria
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
Outcomes
Primary Outcomes
Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups.
Time Frame: At the time of procedure
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.
Secondary Outcomes
- Learning Curve(At time of procedure.)
- Cost(At the time of procedure)
- Diagnostic Characteristics(At time of procedure)
- Accuracy of Predicted Versus Actual Surveillance Intervals(At the time of procedure)