Seoul National University Hospital Gangnam-Real Time Optical Diagnosis Program 2: Gangnam-READI2
Performance of Real-time Optical Diagnosis for Colon Polyp According to the Confidence Rate of Endoscopists
1 other identifier
interventional
8
1 country
1
Brief Summary
Accurate optical diagnosis of colorectal polyps could allow a "resect and discard" strategy based on the results of the optical biopsy. Even though intensive training for optical diagnosis, there is still wide variability in individual endoscopists to meet the PIVI thresholds. The investigators with experience of prior optical diagnosis training perform new education and drill to apply proper high confidence according to their decision time. After the education program, the investigators prospectively evaluate real-time optical biopsy analysis of polyps in 8 academic gastroenterologists.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2020
CompletedFirst Submitted
Initial submission to the registry
March 22, 2020
CompletedFirst Posted
Study publicly available on registry
April 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMarch 2, 2022
February 1, 2022
9 months
March 22, 2020
February 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
PIVI threshold
Negative predictive value for the prediction of nonneoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence
12 months
Study Arms (1)
Feedback
EXPERIMENTALParticipating endoscopists will make high confidence diagnosis according to their judgment time
Interventions
Eligibility Criteria
You may qualify if:
- Board-certified gastroenterologists
- Endoscopists who finished ex-vivo optical diagnosis training
You may not qualify if:
- Inflammatory bowel disease
- Previous colon cancer history
- Previous colon op. history
- Melanosis coli
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Healthcare System Gangnam Center, Seoul National University Hospital
Seoul, South Korea
Related Publications (2)
Bae JH, Lee C, Kang HY, Kwak MS, Doo EY, Seo JY, Song JH, Yang SY, Yang JI, Lim SH, Yim JY, Lim JH, Chung GE, Chung SJ, Jin EH, Park B, Kim JS. Improved Real-Time Optical Diagnosis of Colorectal Polyps Following a Comprehensive Training Program. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2479-2488.e4. doi: 10.1016/j.cgh.2019.02.019. Epub 2019 Feb 14.
PMID: 30772588BACKGROUNDKim J, Lim SH, Kang HY, Song JH, Yang SY, Chung GE, Jin EH, Choi JM, Bae JH. Impact of 3-second rule for high confidence assignment on the performance of endoscopists for the real-time optical diagnosis of colorectal polyps. Endoscopy. 2023 Oct;55(10):945-951. doi: 10.1055/a-2073-3411. Epub 2023 May 12.
PMID: 37172938DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 22, 2020
First Posted
April 17, 2020
Study Start
February 1, 2020
Primary Completion
October 31, 2020
Study Completion
December 31, 2020
Last Updated
March 2, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share