Identification of Colorectal Polyps Clinical Trial
Official title:
Interpretation of Endoscopic Characteristics of Colorectal Polyps With Blue Light Imaging
| Verified date | March 2023 |
| Source | Midwest Veterans' Biomedical Research Foundation |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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
| Status | Not yet recruiting |
| Enrollment | 30 |
| Est. completion date | December 1, 2025 |
| Est. primary completion date | June 1, 2025 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 20 Years to 80 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Midwest Biomedical Research Foundation |
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Accuracy | Accuracy comparison between training and non training groups | 1 year | |
| Secondary | Sensitivity | Sensitivity comparison between training and non training groups | 1 year | |
| Secondary | Specificity | Specificity comparison between training and non training groups | 1 year | |
| Secondary | Positive predictive value | Positive predictive value comparison between training and non training groups | 1 year | |
| Secondary | Negative predictive value | Negative predictive value comparison between training and non training groups | 1 year |