Copyright
©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
AIM
To assess the utility of modified Sano′s (MS) vs the narrow band imaging international colorectal endoscopic (NICE) classification in differentiating colorectal polyps.
METHODS
Patients undergoing colonoscopy between 2013 and 2015 were enrolled in this trial. Based on the MS or the NICE classifications, patients were randomised for real-time endoscopic diagnosis. This was followed by biopsies, endoscopic or surgical resection. The endoscopic diagnosis was then compared to the final (blinded) histopathology. The primary endpoint was the sensitivity (Sn), specificity (Sp), positive predictive value (PPV) and negative predictive value (NPV) of differentiating neoplastic and non-neoplastic polyps (MS II/IIo / IIIa / IIIb vs I or NICE 1 vs 2/3). The secondary endpoints were “endoscopic resectability” (MS II/IIo/IIIa vs I/IIIb or NICE 2 vs 1/3), NPV for diminutive distal adenomas and prediction of post-polypectomy surveillance intervals.
RESULTS
A total of 348 patients were evaluated. The Sn, Sp, PPV and NPV in differentiating neoplastic polyps from non-neoplastic polyps were, 98.9%, 85.7%, 98.2% and 90.9% for MS; and 99.1%, 57.7%, 95.4% and 88.2% for NICE, respectively. The area under the receiver operating characteristic curve (AUC) for MS was 0.92 (95%CI: 0.86-0.98); and AUC for NICE was 0.78 (95%CI: 0.69, 0.88). The Sn, Sp, PPV and NPV in predicting “endoscopic resectability” were 98.9%, 86.1%, 97.8% and 92.5% for MS; and 98.6%, 66.7%, 94.7% and 88.9% for NICE, respectively. The AUC for MS was 0.92 (95%CI: 0.87-0.98); and the AUC for NICE was 0.83 (95%CI: 0.75-0.90). The AUC values were statistically different for both comparisons (P = 0.0165 and P = 0.0420, respectively). The accuracy for diagnosis of sessile serrated adenoma/polyp (SSA/P) with high confidence utilizing MS classification was 93.2%. The differentiation of SSA/P from other lesions achieved Sp, Sn, PPV and NPV of 87.2%, 91.5%, 89.6% and 98.6%, respectively. The NPV for predicting adenomas in diminutive rectosigmoid polyps (n = 150) was 96.6% and 95% with MS and NICE respectively. The calculated accuracy of post-polypectomy surveillance for MS group was 98.2% (167 out of 170) and for NICE group was 92.1% (139 out of 151).
CONCLUSION
The MS classification outperformed the NICE classification in differentiating neoplastic polyps and predicting endoscopic resectability. Both classifications met ASGE PIVI thresholds.
Core tip: Endoscopic differentiation of colorectal polyps can be daunting. Especially with serrated lesions. The Modified Sano’s (MS) classification, the first classification that included sessile serrated adenoma/polyps was developed in 2013. In this randomised controlled trial we compare the accuracies of the well-established narrow band imaging international colorectal endoscopic classification and the MS classification. Although both classifications have met the ASGE PIVI statement thresholds for predicting histology in diminutive rectosigmoid polyps and post-polypectomy surveillance, MS was statistically more accurate.
