AzTrials
AzTrials

Colon PolypsNCT02516748

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

An observational study of Colon Polyps, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Colon Polyps
What is being tested?
Feedback
How many people
3,268 participants
Where
1 siteSouth Korea
Study dates
Aug 2015to Oct 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Healthcare System Gangnam Center, Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Colon Polyps
Being tested
Feedback
Keywords
optical diagnosis, narrow band image
Medical subject headings
Colonic Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FeedbackBehavioural

    Also called Behavior change intervention

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

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 month

Secondary outcomes (6)

  1. Concordance rate in surveillance intervals of follow-up colonoscopy between optical diagnosis and histological diagnosis for polyps assessed with high confidence

    Measured: 12 months

  2. Negative predictive value for neoplastic polyps in rectosigmoid polyps 5mm or smaller with assessed high confidence

    Negative predictive value for neoplastic polyps defined as: number of hyperplastic polyps assessed by histologic diagnosis / number of hyperplastic polyps assessed by optical diagnosis

    Measured: 12 months

  3. The learning curve of accuracy of optical diagnosis

    Measured: 12 months

  4. The maintance of accuracy of optical diagnosis

    Measured: 12 months

  5. Adenoma detection rate

    Measured: 24 month

  6. Serrated lesion detection rate

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionSep 2016
  4. Study completionOct 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
3,268 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02516748
Sponsor's protocol ID
H-1505-019-670
Status last verified
Dec 2017
First submitted
30 Jul 2015
Last updated
15 Dec 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • McGill SK, Evangelou E, Ioannidis JP, Soetikno RM, Kaltenbach T. Narrow band imaging to differentiate neoplastic and non-neoplastic colorectal polyps in real time: a meta-analysis of diagnostic operating characteristics. Gut. 2013 Dec;62(12):1704-13. doi: 10.1136/gutjnl-2012-303965. Epub 2013 Jan 7.

    PubMed 23300139

  • Hassan C, Pickhardt PJ, Rex DK. A resect and discard strategy would improve cost-effectiveness of colorectal cancer screening. Clin Gastroenterol Hepatol. 2010 Oct;8(10):865-9, 869.e1-3. doi: 10.1016/j.cgh.2010.05.018. Epub 2010 Jun 1.

    PubMed 20621680

  • Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.

    PubMed 19910250

  • IJspeert JE, Bastiaansen BA, van Leerdam ME, Meijer GA, van Eeden S, Sanduleanu S, Schoon EJ, Bisseling TM, Spaander MC, van Lelyveld N, Bargeman M, Wang J, Dekker E; Dutch Workgroup serrAted polypS & Polyposis (WASP). Development and validation of the WASP classification system for optical diagnosis of adenomas, hyperplastic polyps and sessile serrated adenomas/polyps. Gut. 2016 Jun;65(6):963-70. doi: 10.1136/gutjnl-2014-308411. Epub 2015 Mar 9.

    PubMed 25753029

  • Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.

    PubMed 22609383

  • 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.

    PubMed 30772588

  • Vleugels JLA, Dijkgraaf MGW, Hazewinkel Y, Wanders LK, Fockens P, Dekker E; DISCOUNT study group. Effects of Training and Feedback on Accuracy of Predicting Rectosigmoid Neoplastic Lesions and Selection of Surveillance Intervals by Endoscopists Performing Optical Diagnosis of Diminutive Polyps. Gastroenterology. 2018 May;154(6):1682-1693.e1. doi: 10.1053/j.gastro.2018.01.063. Epub 2018 Feb 6.

    PubMed 29425923

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Polyps, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concordance rate between optical diagnosis and histologic diagnosis for polyps <10 mm in real-time colonoscopy (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02516748, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in