Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study

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Abstract

Background

Accurate optical characterisation and removal of small adenomas (<10 mm) at colonoscopy would allow hyperplastic polyps to be left in situ and surveillance intervals to be determined without the need for histopathology. Although accurate in specialist practice the performance of narrow band imaging (NBI), colonoscopy in routine clinical practice is poorly understood.

Methods

NBI-assisted optical diagnosis was compared with reference standard histopathological findings in a prospective, blinded study, which recruited adults undergoing routine colonoscopy in six general hospitals in the UK. Participating colonoscopists (N=28) were trained using the NBI International Colorectal Endoscopic (NICE) classification (relating to colour, vessel structure and surface pattern). By comparing the optical and histological findings in patients with only small polyps, test sensitivity was determined at the patient level using two thresholds: presence of adenoma and need for surveillance. Accuracy of identifying adenomatous polyps <10 mm was compared at the polyp level using hierarchical models, allowing determinants of accuracy to be explored.

Findings

Of 1688 patients recruited, 722 (42.8%) had polyps <10 mm with 567 (78.5%) having only polyps <10 mm. Test sensitivity (presence of adenoma, N=499 patients) by NBI optical diagnosis was 83.4% (95% CI 79.6% to 86.9%), significantly less than the 95% sensitivity (p<0.001) this study was powered to detect. Test sensitivity (need for surveillance) was 73.0% (95% CI 66.5% to 79.9%). Analysed at the polyp level, test sensitivity (presence of adenoma, N=1620 polyps) was 76.1% (95% CI 72.8% to 79.1%). In fully adjusted analyses, test sensitivity was 99.4% (95% CI 98.2% to 99.8%) if two or more NICE adenoma characteristics were identified. Neither colonoscopist expertise, confidence in diagnosis nor use of high definition colonoscopy independently improved test accuracy.

Interpretation

This large multicentre study demonstrates that NBI optical diagnosis cannot currently be recommended for application in routine clinical practice. Further work is required to evaluate whether variation in test accuracy is related to polyp characteristics or colonoscopist training.

Trial registration number

The study was registered with clinicaltrials.gov (NCT01603927).

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Most cited references 28

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The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002.

H Kashida, CJ Lightdale, R Lambert … (2003)

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Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging.

Shinji Tanaka, David G. Hewett, Douglas Rex … (2012)

Almost all colorectal polyps ≤ 5 mm are benign, yet current practice requires costly pathologic analysis. We aimed to develop and evaluate the validity of a simple narrow-band imaging (NBI)-based classification system for differentiating hyperplastic from adenomatous polyps. The study was conducted in 4 phases: (1) evaluation of accuracy and reliability of histologic prediction by NBI-experienced colonoscopists; (2) development of a classification based on color, vessels, and surface pattern criteria, using a modified Delphi method; (3) validation of the component criteria by people not experienced in endoscopy or NBI analysis (25 medical students, 19 gastroenterology fellows) using 118 high-definition colorectal polyp images of known histology; and (4) validation of the classification system by NBI-trained gastroenterology fellows, using still images. We performed a pilot evaluation during real-time colonoscopy. We developed a classification system for the endoscopic diagnosis of colorectal polyp histology and established its predictive validity. When all 3 criteria were used, the specificity ranged from 94.9% to 100% and the combined sensitivity ranged from 8.5% to 61.0%. The specificities of the individual criteria were lower although the sensitivities were higher. During real-time colonoscopy, endoscopists made diagnoses with high confidence for 75% of consecutive small colorectal polyps, with 89% accuracy, 98% sensitivity, and 95% negative predictive values. We developed and established the validity of an NBI classification system that can be used to diagnose colorectal polyps. In preliminary real-time evaluation, the system allowed endoscopic diagnoses of colorectal polyp histology. Copyright © 2012 AGA Institute. Published by Elsevier Inc. All rights reserved.

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The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps.

Douglas Rex, Charles Kahi, Michael V O'brien … (2011)

The PIVI (Preservation and Incorporation of Valuable endoscopic Innovations) initiative is an ASGE program whose objectives are to identify important clinical questions related to endoscopy and to establish a priori diagnostic and/or therapeutic thresholds for endoscopic technologies designed to resolve these clinical questions. Additionally, PIVIs may also outline the data and or the research study design required for proving an established threshold is met. Once endoscopic technologies meet an established PIVI threshold, those technologies are appropriate to incorporate into clinical practice presuming the appropriate training in that endoscopic technology has been achieved. The ASGE encourages and supports the appropriate use of technologies that meet its established PIVI thresholds. The PIVI initiative was developed primarily to direct endoscopic technology development toward resolving important clinical issues in endoscopy. The PIVI initiative is also designed to minimize the possibility that potentially valuable innovations are prematurely abandoned due to lack of utilization and to avoid widespread use of an endoscopic technology before clinical studies documenting their effectiveness have been performed. The following document, or PIVI, is one of a series of statements defining the diagnostic or therapeutic threshold that must be met for a technique or device to become considered appropriate for incorporation into clinical practice. It is also meant to serve as a guide for researchers or those seeking to develop technologies that are designed to improve digestive health outcomes. An ad hoc committee under the auspices of the existing ASGE Technology and Standards of Practice Committees Chairs develops PIVIs. An expert in the subject area chairs the PIVI, with additional committee members chosen for their individual expertise. In preparing this document, evidence-based methodology was employed, using a MEDLINE and PubMed literature search to identify pertinent clinical studies on the topic. PIVIs are ultimately submitted to the ASGE Governing Board for approval, as is done for all Technology and Standards of Practice documents. This document is provided solely for educational and informational purposes and to support incorporating these endoscopic technologies into clinical practice. It should not be construed as establishing a legal standard of care. Copyright © 2011. Published by Mosby, Inc.

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Author and article information

Journal

Journal ID (nlm-ta): Gut

Journal ID (iso-abbrev): Gut

Journal ID (hwp): gutjnl

Journal ID (publisher-id): gut

Title: Gut

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Print): 0017-5749

ISSN (Electronic): 1468-3288

Publication date (Print): May 2017

Publication date (Electronic): 19 April 2016

Volume: 66

Issue: 5

Pages: 887-895

Affiliations

[1 ]Department of Gastroenterology, South Tyneside NHS Foundation Trust , South Shields, UK

[2 ]School of Medicine, Pharmacy and Health, Durham University , Durham, UK

[3 ]Northern Region Endoscopy Group, UK

[4 ]St Mark's Hospital and Academic Institute, London North West Healthcare NHS Trust, Imperial College London , London, UK

[5 ]Durham Clinical Trials Unit, School of Medicine Pharmacy & Health, Durham University , Stockton-on-Tees, UK

[6 ]Department of Gastroenterology, North Tees & Hartlepool NHS Foundation Trust , Stockton-on-Tees, UK

[7 ]Translational Gastroenterology Unit, John Radcliffe Hospital, University of Oxford , Oxford, UK

[8 ]Department of Gastroenterology, Northumbria Healthcare NHS Foundation Trust , Newcastle upon Tyne, UK

[9 ]Department of Gastroenterology, North Cumbria University Hospitals NHS Trust , Carlisle, UK

[10 ]Department of Gastroenterology, South Tees Hospitals NHS Foundation Trust , Middlesborough, UK

[11 ]Department of Gastroenterology, County Durham & Darlington NHS Foundation Trust , Darlington, UK

[12 ]Warwick Medical School, University of Warwick , Coventry, UK

Author notes

[Correspondence to ] Professor Colin J Rees, Department of Gastroenterology, South Tyneside District Hospital, South Shields NE34 0PL, UK; Colin.Rees@ 123456stft.nhs.uk

Article

Publisher ID: gutjnl-2015-310584

DOI: 10.1136/gutjnl-2015-310584

PMC ID: 5531217

PubMed ID: 27196576

Copyright statement: Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

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ScienceOpen disciplines: Gastroenterology & Hepatology

Keywords: colonic neoplasms, colorectal adenomas, colonoscopy, endoscopy

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Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study

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Abstract

Background

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Interpretation

Trial registration number

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Karger: Gastroenterology

Most cited references 28

The Paris endoscopic classification of superficial neoplastic lesions: esophagus, stomach, and colon: November 30 to December 1, 2002.

Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging.

The American Society for Gastrointestinal Endoscopy PIVI (Preservation and Incorporation of Valuable Endoscopic Innovations) on real-time endoscopic assessment of the histology of diminutive colorectal polyps.

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Cited by 25

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