Interpretation of Endoscopic Characteristics of Colorectal Polyps With Blue Light Imaging

Interpretation of endoscopic characteristics of colorectal polyps with Blue Light Imaging A study of BLI images and videos of colorectal polyps will be presented initially as a training set followed by with explanation and teaching in a didactic session to two separate groups. A post-test will be conducted to look at the quality of the learning experience.

To evaluate the teaching tool regarding the criteria for BLI images of colorectal polyps by the following measures

• Inter-observer agreement between same and different groups
• Accuracy in describing the morphology of colorectal polyps • This new teaching tool will improve
• Inter-observer agreement by at least 5%- 10% (depending on the group)
• Accuracy by at least 5%- 10% (depending on the group)• To determine the improvement of inter-observer agreement in identifying/ describing colorectal polyps after the didactic session in both the groups
• Overall Accuracy, Sensitivity, Specificity, Positive predictive value and negative predictive value pre-and post-test in both the groups

Study Overview

• Status: Not yet recruiting
• Conditions: Identification of Colorectal Polyps
• Intervention / Treatment: Other: Teaching tool for identification of colorectal polyps

• Study Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study participants are contacted while they are at the VA medical centre. All gastroenterology attending physicians, gastroenterology fellows, residents and medical students will be notified about the study and asked about the willingness to participate if they fit the inclusion/exclusion criteria. Practicing gastroenterologists and trainees will be contacted and inquired about their intent of participating in the assessment of images/videos. This is a voluntary project and not a part of any mandatory training. There is no coercion of participants who do not want to participate.

This study includes only the images and videos from standard pre-existing database. This database was developed by European investigators for educational purposes. This information has no patient identifiable parameters. This information is stored in a secure server with guarded access.

Description

Inclusion Criteria All gastroenterology attending physicians, gastroenterology fellows, residents and medical students at the VA medical center

Exclusion Criteria Not willing to participate H/O colour blindness or visual impairment Any intellectual disability

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Training group	Other: Teaching tool for identification of colorectal polyps; This is a teaching session on how to identify the colorectal polyps shot in blue light imaging.
Non-Training group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
inter-observer agreement in identifying/ describing colorectal polyps	it is measured by kappa statistic which measures the agreements of the total interpretations	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy	Accuracy comparison between training and non training groups	1 year
Sensitivity	Sensitivity comparison between training and non training groups	1 year
Specificity	Specificity comparison between training and non training groups	1 year
Positive predictive value	Positive predictive value comparison between training and non training groups	1 year
Negative predictive value	Negative predictive value comparison between training and non training groups	1 year

Collaborators and Investigators

• Sponsor: Midwest Biomedical Research Foundation

Publications and helpful links

General Publications

• Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.
• Rastogi A, Keighley J, Singh V, Callahan P, Bansal A, Wani S, Sharma P. High accuracy of narrow band imaging without magnification for the real-time characterization of polyp histology and its comparison with high-definition white light colonoscopy: a prospective study. Am J Gastroenterol. 2009 Oct;104(10):2422-30. doi: 10.1038/ajg.2009.403. Epub 2009 Jul 7.
• Togashi K, Nemoto D, Utano K, Isohata N, Kumamoto K, Endo S, Lefor AK. Blue laser imaging endoscopy system for the early detection and characterization of colorectal lesions: a guide for the endoscopist. Therap Adv Gastroenterol. 2016 Jan;9(1):50-6. doi: 10.1177/1756283X15603614.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2024
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: June 14, 2018
• First Submitted That Met QC Criteria: June 14, 2018
• First Posted (Actual): June 26, 2018

Study Record Updates

• Last Update Posted (Actual): March 16, 2023
• Last Update Submitted That Met QC Criteria: March 15, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Polyps
• Other Study ID Numbers: 00983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No need of sharing as the participants are the institutional ones

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No