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

Not Applicable

Completed

• Conditions: Colon Polyp
• Interventions: Behavioral: feedback

• Registration Number: NCT04350840
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-02-01
• Study First Submitted: 2020-03-22
• Study First Submitted QC: 2020-04-15
• Study First Posted: 2020-04-17
• Primary Completion: 2020-10-31
• Study Completion: 2020-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-14
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

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

Exclusion Criteria

1. Inflammatory bowel disease
2. Previous colon cancer history
3. Previous colon op. history
4. Melanosis coli

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Feedback	feedback	Participating endoscopists will make high confidence diagnosis according to their judgment time

Primary Outcome Measures

Name	Time	Method
PIVI threshold	12 months	Negative predictive value for the prediction of nonneoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence

Trial Locations

Locations (1)

Healthcare System Gangnam Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of