Interpretation of Endoscopic Characteristics of Colorectal Polyps With Blue Light Imaging

NCT03569124 — Unknown, 30 participants, Midwest Biomedical Research

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  
RegistryNCT03569124
StatusUnknown
Study typeObservational
Enrollment30 (Estimated)
SponsorMidwest Biomedical Research (Other)
ConditionsIdentification of Colorectal Polyps
InterventionsTeaching tool for identification of colorectal polyps (Other)
Datesstart 2024-10-01 (estimated), primary completion 2025-06-01 (estimated), completion 2025-12-01 (estimated), first posted 2018-06-26, last updated 2023-03-16

Related Papers Related Patents Related Grants Related Experts
All trials for Identification of Colorectal Polyps All trials of Teaching tool for identification of colorectal polyps

-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

Expand all sections  ·  Collapse all

+Arms and interventions

ArmTypeInterventionsDescription
Training groupOther: Teaching tool for identification of colorectal polyps
Non-Training group
  • Teaching tool for identification of colorectal polyps (Other): This is a teaching session on how to identify the colorectal polyps shot in blue light imaging.

+Outcome measures

Primary outcomes

  • inter-observer agreement in identifying/ describing colorectal polyps [1 year]: it is measured by kappa statistic which measures the agreements of the total interpretations

Secondary outcomes

  • Accuracy [1 year]: Accuracy comparison between training and non training groups
  • Sensitivity [1 year]: Sensitivity comparison between training and non training groups
  • Specificity [1 year]: Specificity comparison between training and non training groups
  • Positive predictive value [1 year]: Positive predictive value comparison between training and non training groups
  • Negative predictive value [1 year]: Negative predictive value comparison between training and non training groups

+Eligibility

Sex: All, ages: 20 Years to 80 Years

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

+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. PMID 22609383
  • 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. PMID 19584829
  • 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. Ther Adv Gastroenterol. 2016 Jan;9(1):50-6. doi: 10.1177/1756283X15603614. PMID 26770267