Clinical trial NCT03569124: Interpretation of Endoscopic Characteristics of Colorectal Polyps With Blue Light Imaging
Official title: Interpretation of Endoscopic Characteristics of Colorectal Polyps With Blue Light Imaging
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Identification of Colorectal Polyps
Lead sponsor: Midwest Veterans' Biomedical Research Foundation
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: inter-observer agreement in identifying/ describing colorectal polyps
timeFrame: 1 year
Secondary outcomes:
measure: Accuracy
timeFrame: 1 year
measure: Sensitivity
timeFrame: 1 year
measure: Specificity
timeFrame: 1 year
measure: Positive predictive value
timeFrame: 1 year
measure: Negative predictive value
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.