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Practice-Based Learning to Predict Polyp Histology at Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01638091
First received: July 6, 2012
Last updated: July 10, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Colonic Polyps
Adenomatous Polyps
 Behavioral: Ex vivo module
Behavioral: In vivo practice-base learning phase

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Practice-Based Learning to Predict Polyp Histology at Colonoscopy: A Demonstration Project in Community Practice

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Learning curves [ Time Frame: 6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Agreement between NBI-aided surveillance recommendations vs. those based on pathology examination of all polyps


Enrollment: 14
Study Start Date: March 2011
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Community-based endoscopist who performs screening colonoscopy

Exclusion Criteria:

  • Inability or lack of willingness to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01638091

Locations
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
  More Information

No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01638091     History of Changes
Other Study ID Numbers: HSR-10-1167, IRB-20373
Study First Received: July 6, 2012
Last Updated: July 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Narrow band imaging
Screening colonoscopy
Histology

Additional relevant MeSH terms:
Colonic Polyps
Polyps
Adenomatous Polyps
Intestinal Polyps
Pathological Conditions, Anatomical
 Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 18, 2013