Seoul National University Hospital Gangnam-Real Time Optical Diagnosis Program 2: Gangnam-READI2

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colon Polyp Colonic Polyps Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, South Korea

About this study

This study is an extension of the Gangnam-READI program (NCT02516748) in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of two periods. First, an education program on predicting polyp histology and real-time optical diagnosis will be performed by 8 endoscopists From February to March 2020. In the second period from April 2020 till October 2020(total 6 months), real-time optical diagnosis with time drill for diminutive and small colorectal polyps will be activated. Endoscopists will have 3 seconds rule to make high confidence diagnosis and have feedbacks on their accuracy of optical diagnosis for polyps per 3 months. The performance will be evaluated by comparing the optically predicted diagnosis with the actual histologic diagnosis. Negative predictive value for the prediction of non-neoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence will be measured. In addition, the characteristics of the endoscopist affecting the performance of optical diagnosis were investigated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Board-certified gastroenterologists
Endoscopists who finished ex-vivo optical diagnosis training

Exclusion criteria

Inflammatory bowel disease
Previous colon cancer history
Previous colon op. history
Melanosis coli

Treatment and study plan

Feedback

Behavioral

feedback of optical diagnosis performance per 3 month

Primary outcomes

PIVI threshold

Time frame: 12 months

Negative predictive value for the prediction of nonneoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Performance of Real-time Optical Diagnosis for Colon Polyp According to the Confidence Rate of Endoscopists

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Apr 17, 2020
Registry last updated: Mar 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed