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

April 30, 2018 updated by: Roy Soetikno, VA Palo Alto Health Care System

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

558

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Veterans Affairs Palo Alto
    • Missouri
      • Kansas City, Missouri, United States, 64128
        • Veterans Affairs Kansas City

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the time of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
At the time of procedure
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
At time of procedure
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.
At the time of procedure
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.
At time of procedure.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Palo Alto Health Care System

Collaborators

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

February 1, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (ESTIMATE)

February 2, 2011

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VALID PA19624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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