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

NCT ID: NCT04350840

Last Updated: 2022-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-01
• Study Completion Date: 2020-12-31

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.

Conditions

Colon Polyp

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Feedback

Participating endoscopists will make high confidence diagnosis according to their judgment time

Group Type: EXPERIMENTAL

feedback

Intervention Type: BEHAVIORAL

feedback of optical diagnosis performance per 3 month

Interventions

feedback

feedback of optical diagnosis performance per 3 month

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Su Jin Chung

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: BACKGROUND

PMID: 30772588 (View on PubMed)

Kim 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.

Reference Type: DERIVED

PMID: 37172938 (View on PubMed)

Other Identifiers

H-2001083-1095

Identifier Type: -

Identifier Source: org_study_id