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

Primary Purpose

Colon Polyp

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
feedback
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Colon Polyp

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Healthcare System Gangnam Center, Seoul National University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Feedback

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 22, 2020
Last Updated
February 14, 2022
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04350840
Brief Title
Seoul National University Hospital Gangnam-Real Time Optical Diagnosis Program 2: Gangnam-READI2
Official Title
Performance of Real-time Optical Diagnosis for Colon Polyp According to the Confidence Rate of Endoscopists
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Polyp

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Feedback
Arm Type
Experimental
Arm Description
Participating endoscopists will make high confidence diagnosis according to their judgment time
Intervention Type
Behavioral
Intervention Name(s)
feedback
Intervention Description
feedback of optical diagnosis performance per 3 month
Primary Outcome Measure Information:
Title
PIVI threshold
Description
Negative predictive value for the prediction of nonneoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence
Time Frame
12 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Healthcare System Gangnam Center, Seoul National University Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30772588
Citation
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.
Results Reference
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Learn more about this trial

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

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