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

VA Palo Alto Health Care System

Status: Completed

Conditions: Colonic Polyps; Colorectal Neoplasm

Treatments: Device: Close focus HD NBI Colonoscopy System

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01288833

VALID PA19624

Details and patient eligibility

About

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.

Full 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.

Enrollment: 558 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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558 participants in 2 patient groups

Close focus HD NBI Colonoscopy System

Experimental group

Description:

Use of close focus to make optical diagnosis

Treatment:

Device: Close focus HD NBI Colonoscopy System

Current HD NBI Colonoscopy System

No Intervention group

Description:

Use of standard focus for optical diagnosis