Overview

This trial is active, not recruiting.

Conditions colorectal neoplasm, colonic polyps
Treatment close focus hd nbi colonoscopy system
Phase phase 3
Sponsor VA Palo Alto Health Care System
Collaborator Kansas City Veteran Affairs Medical Center
Start date March 2011
End date June 2017
Trial size 558 participants
Trial identifier NCT01288833, VALID PA19624

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose diagnostic
Arm
(Experimental)
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.
(No Intervention)
Use of standard focus for optical diagnosis

Primary Outcomes

Measure
Compare the number of accurate high confidence polyp histology predictions by the endoscopist in the two groups.
time frame: 12 months

Secondary Outcomes

Measure
Cost
time frame: 1 year
Diagnostic characteristics
time frame: 12 months
Accuracy of predicted versus actual surveillance intervals
time frame: 12 months
Surveillance Colonoscopy Advanced Pathology Findings
time frame: 5 years
Learning Curve
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Principal investigator Tonya Kaltenbach, MD MS
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, measure advanced pathology and colon cancer at surveillance, and measure complications.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by VA Palo Alto Health Care System.