Randomized Controlled Trial
Copyright ©The Author(s) 2017. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Jun 16, 2017; 9(6): 273-281
Published online Jun 16, 2017. doi: 10.4253/wjge.v9.i6.273
Multicenter randomised controlled trial comparing the high definition white light endoscopy and the bright narrow band imaging for colon polyps
Rajvinder Singh, Kuan Loong Cheong, Leonardo Zorron Cheng Tao Pu, Dileep Mangira, Doreen Siew Ching Koay, Carmen Kee, Siew Chien Ng, Rungsun Rerknimitr, Satimai Aniwan, Tiing-Leong Ang, Khean-Lee Goh, Shiaw Hooi Ho, James Yun-Wong Lau
Rajvinder Singh, Kuan Loong Cheong, Leonardo Zorron Cheng Tao Pu, Doreen Siew Ching Koay, Gastroenterology Department, Lyell McEwin Hospital (NALHN), SA 5112, Australia
Rajvinder Singh, Leonardo Zorron Cheng Tao Pu, School of Medicine, the University of Adelaide, SA 5000, Australia
Dileep Mangira, Flinders Medical Centre, South Australia, Australia, SA 5042, Australia
Carmen Kee, Siew Chien Ng, James Yun-Wong Lau, Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Rungsun Rerknimitr, Satimai Aniwan, Chulalongkorn University, Bangkok 10330, Thailand
Tiing-Leong Ang, Changi General Hospital, Singapore 529889, Singapore
Khean-Lee Goh, Shiaw Hooi Ho, University of Malaya Medical Centre, Kuala Lumpur 59100, Malaysia
Author contributions: Singh R and Lau JYW conceptualized and designed this study; Singh R, Cheong KL, Mangira D, Koay DSC, Ng SC, Rerknimitr R, Aniwan S, Ang TL, Goh LK, Ho SH and Lau JYW recruited the patients involved in this study; Singh R, Cheong KL, Zorron Cheng Tao Pu L, Kee C and Lau JYW interpreted the data, performed statistical analyses, and edited the manuscript into its final version to be published.
Institutional review board statement: Institutional medical and ethics committees of each participating hospital approved the study protocol.
Clinical trial registration statement: This study is registered at https://clinicaltrials.gov. The registration identification number is NCT01422577.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The authors declared no conflicting interests (including, but not limited to, commercial, personal, political, intellectual, or religious interests) related to the manuscript submitted for consideration of publication.
Data sharing statement: Technical appendix and dataset available from the corresponding author at rajvinder.singh@sa.gov.au. Participants gave informed consent for data sharing.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is 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/
Correspondence to: Dr. Rajvinder Singh, Professor of Medicine, Director of Gastroenterology, Gastroenterology Department, Lyell McEwin Hospital (NALHN), Haydown Road, Elizabeth Vale, SA 5112 Australia. rajvinder.singh@sa.gov.au
Telephone: +61-8-81829909 Fax: +61-8-81829837
Received: January 17, 2017
Peer-review started: January 19, 2017
First decision: March 13, 2017
Revised: April 4, 2017
Accepted: May 18, 2017
Article in press: May 19, 2017
Published online: June 16, 2017
Abstract
AIM

To compare high definition white light endoscopy and bright narrow band imaging for colon polyps’ detection rates.

METHODS

Patients were randomised to high definition white light endoscopy (HD-WLE) or the bright narrow band imaging (bNBI) during withdrawal of the colonoscope. Polyps identified in either mode were characterised using bNBI with dual focus (bNBI-DF) according to the Sano’s classification. The primary outcome was to compare adenoma detection rates (ADRs) between the two arms. The secondary outcome was to assess the negative predictive value (NPV) in differentiating adenomas from hyperplastic polyps for diminutive rectosigmoid lesions.

RESULTS

A total of 1006 patients were randomised to HD-WLE (n = 511) or bNBI (n = 495). The mean of adenoma per patient was 1.62 and 1.84, respectively. The ADRs in bNBI and HD-WLE group were 37.4% and 39.3%, respectively. When adjusted for withdrawal time (OR = 1.19, 95%CI: 1.15-1.24, P < 0.001), the use of bNBI was associated with a reduced ADR (OR = 0.69, 95%CI: 0.52-0.92). Nine hundred and thirty three polyps (86%) in both arms were predicted with high confidence. The sensitivity (Sn), specificity (Sp), positive predictive value and NPV in differentiating adenomatous from non-adenomatous polyps of all sizes were 95.9%, 87.2%, 94.0% and 91.1% respectively. The NPV in differentiating an adenoma from hyperplastic polyp using bNBI-DF for diminutive rectal polyps was 91.0%.

CONCLUSION

ADRs did not differ between bNBI and HD-WLE, however HD-WLE had higher ADR after adjustment of withdrawal time. bNBI surpassed the PIVI threshold for diminutive polyps.

Keywords: Narrow band imaging, Dual focus, High definition, White light endoscopy, Colon, Polyps, Randomised controlled trial

Core tip: Adenoma detection rate (ADR) is one of the most important quality measures in colonoscopy and bright narrow band imaging (bNBI) can theoretically improve imaging and thus reconnaissance of colorectal polyps. In addition, the magnification using bNBI with dual focus (bNBI-DF) allows the prediction of the polyp’s histology. This multicenter randomised controlled trial was conceived to compare the ADR of high definition white light endoscopy (HD-WLE) vs bNBI during withdrawal of screening colonoscopies. No difference was found in ADR between HD-WLE and bNBI. The prediction of diminutive distal polyps with bNBI-DF was satisfactory according to the American Society for Gastrointestinal Endoscopy’s threshold.