Clinical trial NCT02516748: Real-time Diagnosis of Colorectal Polyps Using Narrow-Band Imaging
Official title: Prospective Study of Real-time Diagnosis of Colorectal Polyps Using Narrow-Band Imaging: Gangnam-ReaDi Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Polyps
Keywords: optical diagnosis
narrow band image
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-08-06
Enrollment: 3268
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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). 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Concordance rate between optical diagnosis and histologic diagnosis for polyps <10 mm in real-time colonoscopy
timeFrame: 12 month
Secondary outcomes:
measure: Concordance rate in surveillance intervals of follow-up colonoscopy between optical diagnosis and histological diagnosis for polyps assessed with high confidence
timeFrame: 12 months
measure: Negative predictive value for neoplastic polyps in rectosigmoid polyps 5mm or smaller with assessed high confidence
timeFrame: 12 months
measure: The learning curve of accuracy of optical diagnosis
timeFrame: 12 months
measure: The maintance of accuracy of optical diagnosis
timeFrame: 12 months
measure: Adenoma detection rate
timeFrame: 24 month
measure: Serrated lesion detection rate
timeFrame: 24 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Healthcare System Gangnam Center, Seoul National University Hospital
Study officials:
affiliation: Department of Internal Medicine and Healthcare Research, Healthcare System, Seoul National University Hospital
name: Su Jin Chung, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.
citation: 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.