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Practice-Based Learning to Predict Polyp Histology at Colonoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01638091
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
Information provided by (Responsible Party):
Stanford University

Brief Summary:

Most colorectal cancers arise from polyps. Most polyps removed at colonoscopy are small. New technologies such as narrowband imaging (NBI) offer the possibility of in differentiation between precancerous and unimportant small polyps. Use of these technologies could decrease the costs and potentially the risks of screening and surveillance colonoscopy.

Multiple studies have demonstrated the ability of experienced endoscopists to achieve high accuracy in differentiating polyp types using NBI.

The investigators hypothesize that community-based endoscopists can learn to identify polyp type at colonoscopy with the aid of NBI through the use of an introductory didactic program, followed by practice based-learning, and that their experience can serve as guidelines for wider dissemination.

The purpose of this study is to test an educational program combining a didactic program followed by practice-based learning that is designed to allow community-based endoscopists to become proficient at the use of NBI in the colon. This study will not affect the care of patients in any way. The research subjects will be the endoscopists, who will perform colonoscopy and polyp removal in the usual clinical fashion, with the addition of attempting to predict polyp type before resection.

Condition or disease Intervention/treatment Phase
Colonic Polyps Adenomatous Polyps Behavioral: Ex vivo module Behavioral: In vivo practice-base learning phase Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Practice-Based Learning to Predict Polyp Histology at Colonoscopy: A Demonstration Project in Community Practice
Study Start Date : March 2011
Actual Primary Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: All participating endoscopists
All endoscopists will undergo ex vivo training and will participate in in vivo practice-based learning.
Behavioral: Ex vivo module
Pre-test, ex vivo computerized training module, post-test

Behavioral: In vivo practice-base learning phase
Prediction of polyp histology in real time, comparison to pathology reports, and review of cumulative individual performance.

Primary Outcome Measures :
  1. Proportion of participants achieving 90% accuracy [ Time Frame: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps ]
    Success for a participant was defined as achieving ≥90% accuracy in optical diagnosis of diminutive polyps. This was based on the last 30 consecutive independent diminutive polyps per participant at one of three pre-specified points (at polyp #50, 70 or 90).

Secondary Outcome Measures :
  1. Learning curves [ Time Frame: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps ]
    Leraning curves as a function of polyp batch, for sensitivity, specificity, positive and negative predictive values, and accuracy

  2. Surveillance recommendations [ Time Frame: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps ]
    Agreement between NBI-aided surveillance recommendations vs. those based on pathology examination of all polyps

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Community-based endoscopist who performs screening colonoscopy

Exclusion Criteria:

  • Inability or lack of willingness 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 identifier (NCT number): NCT01638091

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United States, California
Stanford University
Stanford, California, United States, 94305
United States, Michigan
Huron Gastroenterology
Ann Arbor, Michigan, United States, 48106
Sponsors and Collaborators
Stanford University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stanford University Identifier: NCT01638091    
Other Study ID Numbers: HSR-10-1167
IRB-20373 ( Other Identifier: Stanford University IRB )
First Posted: July 11, 2012    Key Record Dates
Last Update Posted: July 11, 2012
Last Verified: July 2012
Keywords provided by Stanford University:
Narrow band imaging
Screening colonoscopy
Additional relevant MeSH terms:
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Adenomatous Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type