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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
Roy Soetikno, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01288833
First received: February 1, 2011
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasm
Colonic Polyps
Device: Close focus HD NBI Colonoscopy System
Phase 3

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

Resource links provided by NLM:


Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Compare the number of accurate high confidence polyp histology predictions by the endoscopist in the two groups. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Cost [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Measure the cost of colonoscopy with macroscopic histopathologic diagnosis of colorectal lesions compared to colonoscopy with conventional microscopic histopathologic diagnosis, on the lesions that were managed based on an accurate endoscopic diagnosis.

  • Diagnostic characteristics [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare the diagnostic characteristics (accuracy, sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without close focus features.

  • Accuracy of predicted versus actual surveillance intervals [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Compare the accuracy of predicted versus actual surveillance colonoscopy interval recommendations

  • Surveillance Colonoscopy Advanced Pathology Findings [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    Compare the advanced pathology and colon cancer incidence at surveillance colonoscopy of the groups who underwent high definition narrow band imaging colonoscopy with and without close focus features, and more specifically who underwent macroscopic versus microscopic polyp management.

  • Learning Curve [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Examine the impact of a learning curve (i.e. accuracy with low and high confidence at each of endoscopist's first 25% of exams versus last 25% exams)


Enrollment: 558
Study Start Date: March 2011
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Close focus HD NBI Colonoscopy System
Use of close focus to make optical diagnosis
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.
No Intervention: Current HD NBI Colonoscopy System
Use of standard focus for optical diagnosis

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, measure advanced pathology and colon cancer at surveillance, and measure complications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288833

Locations
United States, California
Veterans Affairs Palo Alto
Palo Alto, California, United States, 94304
United States, Missouri
Veterans Affairs Kansas City
Kansas City, Missouri, United States, 64128
Sponsors and Collaborators
VA Palo Alto Health Care System
Kansas City Veteran Affairs Medical Center
Investigators
Principal Investigator: Tonya Kaltenbach, MD MS Veterans Affairs Palo Alto
Principal Investigator: Roy Soetikno, MD MS Veterans Affairs Palo Alto
  More Information

Publications:

Responsible Party: Roy Soetikno, Co-Principal Investigator, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01288833     History of Changes
Other Study ID Numbers: VALID PA19624
Study First Received: February 1, 2011
Last Updated: June 11, 2014
Health Authority: United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:
Colonoscopy
Diagnostic Imaging
Colorectal Neoplasm
Primary Prevention
Cost and Cost Analysis
Endoscopy

Additional relevant MeSH terms:
Neoplasms
Colonic Polyps
Colorectal Neoplasms
Polyps
Intestinal Polyps
Pathological Conditions, Anatomical
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 23, 2014