Real-time Diagnosis of Colorectal Polyps Using Narrow-Band Imaging

December 13, 2017 updated by: Su Jin Chung, Seoul National University Hospital

Prospective Study of Real-time Diagnosis of Colorectal Polyps Using Narrow-Band Imaging: Gangnam-ReaDi Study

Accurate optical diagnosis of colorectal polyps could allow a "resect and discard" strategy with surveillance intervals determined based on the results of the optical biopsy. The investigators perform education to characterize the histology of diminutive and small colorectal polyps by using narrow band imaging (NBI). After education program, the investigators prospectively evaluate real-time optical biopsy analysis of polyps with NBI by 15 gastroenterologists at a medical check up center.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of four periods.

First, a computer based education program on the accuracy of predicting polyp histology with NBI (NICE and WASP classification) will be performed by 15 endoscopists (less experienced in NBI) during Septepber 2015.

In the second period from October 2015 till Deceber 2015, 1st phase real- time optical diagnosis for diminutive and small colorectal polyps will be activated. All endoscopists will have weekly feedback on their accuracy of optical diagnosis for polyps, and discuss the NBI findings that mismatched by histologic diagnosis all together per one month.

Third, the result of 1st phase real-time optical diagnosis will be analyzed from January 2016 till April 2016. In this period, endoscopists with low accuracy of 1st phase real-time optical diagnosis will be re-educated.

The last period from May 2016 till September 2016, 2nd phase real-time optical diagnosis for polyps will be activated. Performance will be evaluated by comparing optically predicted diagnosis with actual histologic diagnosis. Cumulative sum analysis will be used to determine the learning curve for each endoscopist. Negative predictive value for the prediction of nonneoplastic polyp and concordance of surveillance intervals for diminutive polyps diagnosed optically with high confidence will also be measured.

Study Type

Observational

Enrollment (Actual)

3268

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Healthcare System Gangnam Center, Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Customers who received colonoscopy for screening and surveillance of colorectal neoplasia in Seoul National University Hospital Healthcare System Gangnam Center from October 2015 to September 2016.

Description

Inclusion Criteria:

  • Customers who received screening and surveillance colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from October 2015 to September 2016.

Exclusion Criteria:

  • Age <18 years
  • Customers who refused to offer their health check up data
  • History of inflammatory bowel disease
  • History of familial adenomatous polyposis
  • Customers who received Incomplete colonoscopy
  • History of previous colorectal resection
  • Incomplete data collection on optical diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Concordance rate between optical diagnosis and histologic diagnosis for polyps <10 mm in real-time colonoscopy
Time Frame: 12 month
12 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance rate in surveillance intervals of follow-up colonoscopy between optical diagnosis and histological diagnosis for polyps assessed with high confidence
Time Frame: 12 months
12 months
Negative predictive value for neoplastic polyps in rectosigmoid polyps 5mm or smaller with assessed high confidence
Time Frame: 12 months
Negative predictive value for neoplastic polyps defined as: number of hyperplastic polyps assessed by histologic diagnosis / number of hyperplastic polyps assessed by optical diagnosis
12 months
The learning curve of accuracy of optical diagnosis
Time Frame: 12 months
12 months
The maintance of accuracy of optical diagnosis
Time Frame: 12 months
12 months
Adenoma detection rate
Time Frame: 24 month
24 month
Serrated lesion detection rate
Time Frame: 24 month
24 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Su Jin Chung, M.D., Ph.D., Department of Internal Medicine and Healthcare Research, Healthcare System, Seoul National University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

July 30, 2015

First Submitted That Met QC Criteria

August 3, 2015

First Posted (Estimate)

August 6, 2015

Study Record Updates

Last Update Posted (Actual)

December 15, 2017

Last Update Submitted That Met QC Criteria

December 13, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1505-019-670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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