Colonic Neoplasms Clinical Trial
— ESTIMATEOfficial title:
Online Education Module (ESTIMATE: Estimating Polyp Size With Snare Tool to Improve Measurement Accuracy for Trainee Education) to Accurately Classify Polyp Size
Verified date | November 2023 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Investigators developed an online educational module (ESTIMATE) to teach Gastroenterology (GI) trainees how to estimate polyp size using a snare. Key components include video instruction and real-time feedback incorporated over a 40-item polyp size assessment test. Trainees from GI fellowship programs will be randomized to one of four groups: control (no video, no feedback), video-only, feedback-only, and video + feedback. Participants will classify polyps into one of three size categories:- diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm). Primary outcome is accuracy of polyp size classification [diminutive (1-5 mm), small (6-9 mm), and large (≥10 mm)]. Secondary outcomes include accuracy of exact polyp size (in mm), cumulative accuracy (to plot learning curves), confidence level of polyp size classification, and directionality of inaccuracy (polyp size overestimation vs underestimation).
Status | Active, not recruiting |
Enrollment | 48 |
Est. completion date | December 28, 2024 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - GI trainees who have never received formal training in, nor had participated in a research study on, polyp sizing - Informed consent Exclusion Criteria: - Those who do not complete the educational module during the allotted time |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Denver | Aurora | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Northwestern University, University of California, San Francisco |
United States,
Chaptini L, Chaaya A, Depalma F, Hunter K, Peikin S, Laine L. Variation in polyp size estimation among endoscopists and impact on surveillance intervals. Gastrointest Endosc. 2014 Oct;80(4):652-659. doi: 10.1016/j.gie.2014.01.053. Epub 2014 Mar 27. — View Citation
Gopalswamy N, Shenoy VN, Choudhry U, Markert RJ, Peace N, Bhutani MS, Barde CJ. Is in vivo measurement of size of polyps during colonoscopy accurate? Gastrointest Endosc. 1997 Dec;46(6):497-502. doi: 10.1016/s0016-5107(97)70003-8. — View Citation
Gupta S, Lieberman D, Anderson JC, Burke CA, Dominitz JA, Kaltenbach T, Robertson DJ, Shaukat A, Syngal S, Rex DK. Recommendations for Follow-Up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2020 Mar;115(3):415-434. doi: 10.14309/ajg.0000000000000544. No abstract available. — View Citation
Kaltenbach T, Anderson JC, Burke CA, Dominitz JA, Gupta S, Lieberman D, Robertson DJ, Shaukat A, Syngal S, Rex DK. Endoscopic Removal of Colorectal Lesions-Recommendations by the US Multi-Society Task Force on Colorectal Cancer. Gastrointest Endosc. 2020 Mar;91(3):486-519. doi: 10.1016/j.gie.2020.01.029. Epub 2020 Feb 14. No abstract available. — View Citation
Patel SG, May FP, Anderson JC, Burke CA, Dominitz JA, Gross SA, Jacobson BC, Shaukat A, Robertson DJ. Updates on Age to Start and Stop Colorectal Cancer Screening: Recommendations From the U.S. Multi-Society Task Force on Colorectal Cancer. Am J Gastroenterol. 2022 Jan 1;117(1):57-69. doi: 10.14309/ajg.0000000000001548. Erratum In: Am J Gastroenterol. 2022 Jul 1;117(7):1175. — View Citation
Patel SG, Rastogi A, Austin G, Hall M, Siller BA, Berman K, Yen R, Bansal A, Ahnen DJ, Wani S. Gastroenterology trainees can easily learn histologic characterization of diminutive colorectal polyps with narrow band imaging. Clin Gastroenterol Hepatol. 2013 Aug;11(8):997-1003.e1. doi: 10.1016/j.cgh.2013.02.020. Epub 2013 Mar 1. — View Citation
Utsumi T, Horimatsu T, Seno H. Measurement bias of colorectal polyp size: Analysis of the Japan Endoscopy Database. Dig Endosc. 2019 Sep;31(5):589. doi: 10.1111/den.13447. Epub 2019 Jun 13. No abstract available. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant entered rate of accurate polyp size classification into diminutive (1-5 mm), small (6-9 mm), or large (=10 mm) category on 40 question polyp sizing test. | The gold standard polyp size for the polyp images on the polyp sizing test was determined by affixing the polyp to a cork board post-procedure and measuring it with an adjacent ruler. The actual polyp size was determined by meauring it against the adjacent ruler. Polyps 1-5 mm were categorized as diminutive, polyps 6-9 mm were categorized as small and polyps =10 mm were categorized as large.
Participants completed a 40 item polyp sizing test where participants designated the polyp as either dimunitive (1-5mm), small (6-9mm) or large (=10mm). The primary outcome was the rate that each participant correctly designated polyp size categories based on the gold standard. |
through study completion, estimated 1 year | |
Secondary | Participant entered rate of accurate polyp size by millimeter on 40 question polyp sizing test. | Participant rate of accurate polyp size by millimeter (1mm, 2mm, 3mm, 4mm, 5mm, 6mm, 7mm, 8mm, 9mm, 10mm, 11mm, 12mm, 13mm, 14mm, 15mm, 16mm, 17mm, 18mm, 19mm, 20mm, etc) on 40 question polyp sizing test. | through study completion, estimated 1 year | |
Secondary | Cumulative accuracy of polyp size category classification as participants progress through the 40 item polyp sizing test | Cumulative accuracy of polyp size category classification as participants progress through the 40 item polyp sizing test | through study completion, estimated 1 year | |
Secondary | Participant report of categorical high versus low confidence on each response of the 40 item polyp sizing test | self-reported high vs low confidence of each polyp characterization. High confidence is defined as sufficient self-assessed confidence that participant can make a post-polypectomy surveillance interval recommendation based on their designation. This is categorical selection of "high" vs "low" | through study completion, estimated 1 year | |
Secondary | Proportion of participant responses that underestimate actual polyp size category versus overestimate actual polyp size category on the 40-question polyp sizing test. | Proportion of responses that underestimate actual polyp size category (a small or large polyp categorized as diminutive or a large polyp categorized as small) versus overestimate actual polyp size category (a diminutive or small polyp characterized as large or a diminutive polyp characterized as small). | through study completion, estimated 1 year |
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