NCT01288833

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: VA Palo Alto Health Care System · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Colorectal Neoplasm
• Colonic Polyps

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-06-01
• Completion: 2015-10-01
• First posted: 2011-02-02
• Last updated: 2018-06-01
• Results posted: 2018-04-30

Locations

2 sites across 1 country: United States