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.|
|ClinicalTrials.gov Identifier: NCT01638091|
Recruitment Status : Completed
First Posted : July 11, 2012
Last Update Posted : July 11, 2012
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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).
- 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
- 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
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): NCT01638091
|United States, California|
|Stanford, California, United States, 94305|
|United States, Michigan|
|Ann Arbor, Michigan, United States, 48106|