Interpretation of Endoscopic Characteristics of Colorectal Polyps With Blue Light Imaging

NCT03569124 | Unknown DMC

• 1 other identifier: 00983
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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

Conditions

Identification of Colorectal Polyps

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Accuracy

  1 year

• Sensitivity

  1 year

• Specificity

  1 year

• Positive predictive value

  1 year

• Negative predictive value

  1 year

Study Arms (2)

Training group

Other: Teaching tool for identification of colorectal polyps

Non-Training group

Interventions

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.

Training group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 26770267 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Gastroenterology

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: October 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 16, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share