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Completed

NCT Number: NCT02516748

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Feedback

Behavioral

Less experienced endoscopists in optical diagnosis will receive feedbacks about their own accuracy of optical diagnosis.

Other names: Behavior change intervention

Primary outcomes

  1. Concordance rate between optical diagnosis and histologic diagnosis for polyps <10 mm in real-time colonoscopy

    Time frame: 12 month

Secondary outcomes

  1. 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

  2. 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

  3. The learning curve of accuracy of optical diagnosis

    Time frame: 12 months

  4. The maintance of accuracy of optical diagnosis

    Time frame: 12 months

  5. Adenoma detection rate

    Time frame: 24 month

  6. Serrated lesion detection rate

    Time frame: 24 month

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 6, 2015
Registry last updated
Dec 15, 2017

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.

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