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

Colon Polyps Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02516748
• Other study ID #: H-1505-019-670
• Status: Completed
• Phase: N/A
• First received: July 30, 2015
• Last updated: December 13, 2017
• Start date: August 2015
• Est. completion date: October 2016

Study information

• Verified date: December 2017
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3268
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Polyps
• Polyps

Intervention

Behavioral:
• Feedback
Less experienced endoscopists in optical diagnosis will receive feedbacks about their own accuracy of optical diagnosis.

Locations

Country	Name	City	State
Korea, Republic of	Healthcare System Gangnam Center, Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance rate between optical diagnosis and histologic diagnosis for polyps <10 mm in real-time colonoscopy		12 month
Secondary	Concordance rate in surveillance intervals of follow-up colonoscopy between optical diagnosis and histological diagnosis for polyps assessed with high confidence		12 months
Secondary	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	12 months
Secondary	The learning curve of accuracy of optical diagnosis		12 months
Secondary	The maintance of accuracy of optical diagnosis		12 months
Secondary	Adenoma detection rate		24 month
Secondary	Serrated lesion detection rate		24 month