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

NCT02516748 | Completed DMC

• 1 other identifier: H-1505-019-670
• Study Type: observational
• Target: 3,268
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Polyps

Keywords

optical diagnosis; narrow band image

Outcome Measures

Primary Outcomes (1)

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

  12 month

Secondary Outcomes (6)

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

  12 months

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

  12 months

• The learning curve of accuracy of optical diagnosis

  12 months

• The maintance of accuracy of optical diagnosis

  12 months

• Adenoma detection rate

  24 month

Interventions

Feedback BEHAVIORAL

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

Also known as: Behavior change intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Healthcare System Gangnam Center, Seoul National University Hospital

Seoul, South Korea

Location

Related Publications (7)

• 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.

  PMID: 23300139 BACKGROUND

• 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.

  PMID: 20621680 BACKGROUND

• 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.

  PMID: 19910250 BACKGROUND

• 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.

  PMID: 25753029 BACKGROUND

• 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.

  PMID: 22609383 BACKGROUND

• 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.

  PMID: 30772588 DERIVED

• 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.

  PMID: 29425923 DERIVED

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Su Jin Chung, M.D., Ph.D.

  Department of Internal Medicine and Healthcare Research, Healthcare System, Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: August 6, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

KR (1)