NCT01638091

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2012

Completed
Last Updated

July 11, 2012

Status Verified

July 1, 2012

Enrollment Period

1 year

First QC Date

July 6, 2012

Last Update Submit

July 10, 2012

Conditions

Colonic PolypsAdenomatous Polyps

Keywords

Narrow band imagingScreening colonoscopyHistology

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Learning curves

    6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps

  • Surveillance recommendations

    6-12 months depending on when an endoscopist has assessed 50, 70 and 90 independent diminutive polyps

Study Arms (1)

All participating endoscopists

EXPERIMENTAL

All endoscopists will undergo ex vivo training and will participate in in vivo practice-based learning.

Behavioral: Ex vivo moduleBehavioral: In vivo practice-base learning phase

Interventions

Ex vivo moduleBEHAVIORAL

Pre-test, ex vivo computerized training module, post-test

All participating endoscopists
In vivo practice-base learning phaseBEHAVIORAL

Prediction of polyp histology in real time, comparison to pathology reports, and review of cumulative individual performance.

All participating endoscopists

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Community-based endoscopist who performs screening colonoscopy

You may not qualify if:

  • Inability or lack of willingness to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Huron Gastroenterology

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

  • Ladabaum U, Fioritto A, Mitani A, Desai M, Kim JP, Rex DK, Imperiale T, Gunaratnam N. Real-time optical biopsy of colon polyps with narrow band imaging in community practice does not yet meet key thresholds for clinical decisions. Gastroenterology. 2013 Jan;144(1):81-91. doi: 10.1053/j.gastro.2012.09.054. Epub 2012 Oct 3.

    PMID: 23041328DERIVED

MeSH Terms

Conditions

Colonic PolypsAdenomatous Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsAdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2012

First Posted

July 11, 2012

Study Start

March 1, 2011

Primary Completion

March 1, 2012

Last Updated

July 11, 2012

Record last verified: 2012-07

Locations

US(2)