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©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Endosc. Sep 16, 2018; 10(9): 210-218
Published online Sep 16, 2018. doi: 10.4253/wjge.v10.i9.210
Randomised controlled trial comparing modified Sano’s and narrow band imaging international colorectal endoscopic classifications for colorectal lesions
Leonardo Zorrón Cheng Tao Pu, Kuan Loong Cheong, Doreen Siew Ching Koay, Sze Pheh Yeap, Amanda Ovenden, Mahima Raju, Andrew Ruszkiewicz, Philip W Chiu, James Y Lau, Rajvinder Singh
Leonardo Zorrón Cheng Tao Pu, Kuan Loong Cheong, Doreen Siew Ching Koay, Sze Pheh Yeap, Amanda Ovenden, Rajvinder Singh, Department of Gastroenterology, Lyell McEwin Hospital, Adelaide, SA 5112, Australia
Leonardo Zorrón Cheng Tao Pu, Amanda Ovenden, Mahima Raju, Rajvinder Singh, Medical School, University of Adelaide, Adelaide, SA 5005, Australia
Andrew Ruszkiewicz, Department of Pathology, Lyell McEwin Hospital, Adelaide, SA 5112, Australia
Philip W Chiu, James Y Lau, Department of Surgery, the Chinese University of Hong Kong, New Territories, Hong Kong, China
Author contributions: Zorrón Cheng Tao Pu L organized and analysed the raw soft copy data, created tables and figures and drafted the final version of the manuscript; Cheong KL, Koay DSC and Yeap SP collected the raw hard copy data, and provided interim analysis and drafts; Ovenden A contributed with the conversion of data from hard copy to soft copy and with the logistics for data collection and storage; Raju M assisted with editing and proofreading of the final manuscript; Ruszkiewicz A contributed with specialized Pathology input from the design to the final manuscript; Chiu PW, Lau JY and Singh R designed and coordinated the study. Singh R performed all colonoscopies in this study; All authors reviewed and approved the final manuscript.
Institutional review board statement: This study was approved by the Australian Human Research Ethics Committee (TQEH/LMH/MH).
Clinical trial registration statement: This study is registered at http://clinicaltrials.gov. The registration identification number is NCT02963207.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrolment.
Conflict-of-interest statement: All the authors declare that they have no competing interests.
CONSORT 2010 statement: The authors have read the CONSORT 2010 Statement, and the manuscript was prepared and revised according to the CONSORT 2010 Statement
Open-Access: This article is an open-access article which was 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: Rajvinder Singh, FRACP, FRCP (C), MBBS, MPhil, MRCP, Doctor, Professor, Department of Gastroenterology, Lyell McEwin Hospital, Haydown Road, Elizabeth Vale, Adelaide, SA 5112, Australia.
rajvinder.singh@sa.gov.au
Telephone: +61-8-81829909 Fax: +61-8-81829837
Received: April 26, 2018
Peer-review started: May 4, 2018
First decision: June 15, 2018
Revised: July 22, 2018
Accepted: August 2, 2018
Article in press: August 3, 2018
Published online: September 16, 2018
Processing time: 143 Days and 20.2 Hours
ARTICLE HIGHLIGHTS
Research background
Prediction of polyp histology may prevent unnecessary polypectomies and reduce cost.
Research motivation
The endoscopic differentiation of benign and malignant polyps is sometimes difficult, especially when looking into serrated lesions. Very few endoscopic classifications include the differentiation of sessile serrated lesions [e.g., modified Sano’s (MS)]. These have not being widely used partially due to lack of reliable comparison with the currently used classifications [e.g., narrow band imaging international colorectal endoscopic (NICE)]. The comparison of established classifications with a classification including serrated polyps’ differentiation in a randomised trial could help to support the use of the newer and more comprehensive classifications.
Research objectives
The main objective of this randomised controlled trial is to compare the established adenoma vs non-adenoma NICE classification and the newer neoplastic vs non-neoplastic MS classification.
Research methods
This was a single centre randomised controlled trial (pathologist blinded) comparing the NICE classification with the MS classification for the endoscopic prediction of histology of colorectal lesions during colonoscopy.
Research results
MS classification had significantly higher proportion of high confidence diagnoses compared to NICE. Overall, the MS area under the receiver operating characteristic curve (AUC) was 0.92 and NICE AUC was 0.78 (P = 0.0165). For predicting “endoscopic resectability”, MS AUC was also 0.92 and NICE AUC was 0.83 (P = 0.0420). The accuracy for diagnosis of SSA/P by MS classification was 93.2%. The NPV for diminutive rectosigmoid polyps were 96.6% and 95% in MS and NICE arms respectively. The calculated accuracy of post-polypectomy surveillance was 98.2% for MS and 92.1% for NICE. Utilizing MS, 6.4% of high confidence polyps were misdiagnosed. Utilizing NICE, 7.1% were misdiagnosed.
Research conclusions
The MS classification has shown to be accurate in diagnosing colorectal lesions including sessile serrated adenoma/polyp. Both classifications surpassed the ASGE PIVI thresholds. MS classification may currently be the most accurate and comprehensive endoscopic classification for differentiation of colorectal polyps.
Research perspectives
The use of classifications that incorporate the differentiation of serrated polyps such as the MS classification may be necessary. These should become the standard for adequate characterization of colorectal lesions. Nonetheless validation in different centres is required.
