Practice-Based Learning to Predict Polyp Histology at Colonoscopy

Colonic Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01638091
• Other study ID #: HSR-10-1167
• Secondary ID: IRB-20373
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: July 10, 2012
• Start date: March 2011

Study information

• Verified date: July 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Community-based endoscopist who performs screening colonoscopy

Exclusion Criteria:

• Inability or lack of willingness to provide informed consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Adenomatous Polyps
• Colonic Polyps
• Polyps

Intervention

Behavioral:
• Ex vivo module
Pre-test, ex vivo computerized training module, post-test
• In vivo practice-base learning phase
Prediction of polyp histology in real time, comparison to pathology reports, and review of cumulative individual performance.

Locations

Country	Name	City	State
United States	Huron Gastroenterology	Ann Arbor	Michigan
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants achieving 90% accuracy	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	No
Secondary	Learning curves	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	No
Secondary	Surveillance recommendations	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	No