Practice-Based Learning to Predict Polyp Histology at Colonoscopy

July 10, 2012 updated by: Stanford University

Practice-Based Learning to Predict Polyp Histology at Colonoscopy: A Demonstration Project in Community Practice

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

A) Study Purpose and Rationale Most polyps removed at colonoscopy are small. The natural history of these polyps is not understood completely, but the risk of subsequent cancer in persons with small rectosigmoid adenomas may not be higher than in persons without rectosigmoid adenomas [1]. With improvements in colonoscopic imaging, experienced endoscopists can detect polyps in a large fraction of patients. Removal of all small polyps followed by formal histopathological examination increases the costs associated with colorectal cancer screening, and may increase the risk of complications, depending on the technique that is used for polypectomy.

New technologies such as narrowband imaging (NBI) offer the possibility of in vivo differentiation between adenomatous and hyperplastic polyps. Policies to leave in place small polyps that appear to be hyperplastic, or to remove and discard small polyps after in vivo histologic categorization without formal histopathology review could significantly 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 adenomatous from hyperplastic polyps using NBI [2, 3, 4, 5]. The level of confidence associated with in vivo histologic categorization of a particular polyp is a valuable adjunct measure in determining subsequent clinical management. Dissemination to the community setting of policies that promote in vivo histologic categorization is likely to require practice-based learning.

B) Hypotheses The investigators hypothesize that community-based endoscopists can learn to identify polyp histology at colonoscopy with the aid of NBI through the use of an introductory didactic program, followed by practice based-learning, and that representative learning curves can be generated that can serve as guidelines for wider dissemination.

C) Purpose 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 in vivo histologic characterization of small polyps with the aid of NBI. This study will not require any changes in endoscopists' decisions regarding the indications and methods for polypectomy.

This study will not address directly whether polyps predicted to be hyperplastic or even diminutive adenomas should be left in place, or discarded and not submitted for formal histopathological review.

D) Specific Aims This study has two primary and two secondary aims

  1. One primary aim is to assess the proficiency of community-based endoscopists at ex vivo histologic characterization of polyps using NBI based on photographs before and after a didactic program designed to familiarize them with in vivo histologic characterization.
  2. The central primary aim is to assess whether the currently designed program is effective at training endoscopists to classify adenomatous vs. hyperplastic polyps in practice with at least 90% accuracy.
  3. A secondary aim is to characterize endoscopists' individual and group average learning curves for in vivo histologic characterization using NBI during practice-based learning, with attention to level of confidence, accuracy, sensitivity, specificity and positive and negative predictive values.
  4. Another secondary aim is to determine whether surveillance recommendations that would be made based on in vivo histologic characterization using NBI are comparable to those based on formal histopathological assessment.

E) Timeline for assessments:

Endoscopists' accuracy will be determined at three pre-specified points: after assessment of 50, 70 and 90 independent diminutive polyps (defined as <=5mm polyps, one per study colonoscopy, with random selection in cases of >1 diminutive polyp per study colonoscopy). We estimate that in order to assess 90 independent diminutive polyps, endoscopists will need to participate for 6-12 months.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
      • Stanford, California, United States, 94305
        • Stanford University
    • Michigan
      • Ann Arbor, Michigan, United States, 48106
        • Huron Gastroenterology

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Community-based endoscopist who performs screening colonoscopy

Exclusion Criteria:

  • Inability or lack of willingness 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps
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
6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Stanford University

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 11, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 11, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 10, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HSR-10-1167
  • IRB-20373 (Other Identifier: Stanford University IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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