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

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ClinicalTrials.gov Identifier: NCT01288833
Recruitment Status : Completed
First Posted : February 2, 2011
Results First Posted : April 30, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
Kansas City Veteran Affairs Medical Center
Information provided by (Responsible Party):
Roy Soetikno, VA Palo Alto Health Care System

Brief 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.

Condition or disease Intervention/treatment Phase
Colorectal Neoplasm Colonic Polyps Device: Close focus HD NBI Colonoscopy System Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 558 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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
Study Start Date : March 2011
Actual Primary Completion Date : June 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Rate of Accurate High Confidence Polyp Histology Predictions by the Endoscopist in the Two Groups. [ Time Frame: At the time of procedure ]
    Measure of the percentage of accurate high confidence predictions by the endoscopist in the differentiation of neoplastic from non-neoplastic colorectal lesions, using the high definition NBI colonoscopy with and without close focus features. High confidence was assigned if the polyp had one or more features of Type 2 (neoplasia) or Type 1 (nonneoplasia) in the NICE classification and no features associated with the other histology Note: one patient may have multiple polyps.


Secondary Outcome Measures :
  1. Cost [ Time Frame: At the time of procedure ]

    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.

    A reduction in pathology specimens may improve the efficiency of the procedure and has direct pathology cost savings (as well as indirect savings, which were not measured).


  2. Diagnostic Characteristics [ Time Frame: At time of procedure ]

    Compare the diagnostic characteristics (sensitivity, specificity, positive predictive value and negative predictive value) using the high definition narrow band imaging colonoscopy with and without close focus features.

    Accuracy: number of endoscopic predictions of adenomatous polyps histologically confirmed to be adenomatous/number of predicted hyperplastic polyps confirmed to be hyperplastic out of all polyps Sensitivity: number of endoscopic predictions (optical diagnosis) of adenomatous (neoplastic) polyps out of all histologically confirmed polyps Specificity: number of endoscopic predictions of hyperplastic (non-neoplastic) polyps out of all histologically confirmed polyps PPV: number of histologically confirmed adenomatous polyps out of all endoscopic predictions of adenomatous polyps NPV: number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps Note: a patient may have multiple polyps


  3. Accuracy of Predicted Versus Actual Surveillance Intervals [ Time Frame: At the time of procedure ]
    Compared the accuracy of predicted versus actual surveillance colonoscopy interval recommendations by determining number of patients with correct surveillance interval recommendation.

  4. Learning Curve [ Time Frame: At time of procedure. ]
    Examine the impact of a learning curve (i.e. NPV of high confidence at each of endoscopist's first 50% of exams versus last 50% exams to endoscopically predict polyp histology). NPV is defined as "number of histologically confirmed hyperplastic polyps out of all endoscopic predictions of hyperplastic (non-neoplastic) polyps.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: February 2, 2011    Key Record Dates
Results First Posted: April 30, 2018
Last Update Posted: June 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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