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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Colorectal Neoplasm, Colonic Polyps

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Outcome Measure:

Compare the number of accurate high confidence polyp histology predictions by the endoscopist in the two groups.

Outcome Description:

Measure the number of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition narrow band imaging colonoscopy with and without close focus features.

Outcome Time Frame:

12 months

Safety Issue:

No

Principal Investigator

Tonya Kaltenbach, MD MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Veterans Affairs Palo Alto

Authority:

United States: Federal Government

Study ID:

VALID PA19624

NCT ID:

NCT01288833

Start Date:

March 2011

Completion Date:

December 2012

Related Keywords:

  • Colorectal Neoplasm
  • Colonic Polyps
  • Colonoscopy
  • Diagnostic Imaging
  • Colorectal Neoplasm
  • Primary Prevention
  • Cost and Cost Analysis
  • Endoscopy
  • Neoplasms
  • Colonic Polyps
  • Colorectal Neoplasms
  • Polyps

Name

Location

Veterans Affairs Palo AltoPalo Alto, California  94304
Veterans Affairs Kansas CityKansas City, Missouri  64128