Randomized Controlled Trial
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. May 15, 2023; 15(5): 878-891
Published online May 15, 2023. doi: 10.4251/wjgo.v15.i5.878
Efficacy of image-enhanced endoscopy for colorectal adenoma detection: A multicenter, randomized trial
Zhi-Peng Qi, En-Pan Xu, Dong-Li He, Yan Wang, Bai-Sheng Chen, Xue-Si Dong, Qiang Shi, Shi-Lun Cai, Qi Guo, Ni Li, Xing Li, Hai-Yan Huang, Bing Li, Di Sun, Jian-Guang Xu, Zhang-Han Chen, Ayimukedisi Yalikong, Jin-Yi Liu, Zhen-Tao Lv, Jian-Min Xu, Ping-Hong Zhou, Yun-Shi Zhong
Zhi-Peng Qi, En-Pan Xu, Qiang Shi, Shi-Lun Cai, Bing Li, Di Sun, Zhang-Han Chen, Ayimukedisi Yalikong, Jin-Yi Liu, Zhen-Tao Lv, Ping-Hong Zhou, Yun-Shi Zhong, Endoscopy Center, Zhongshan Hospital of Fudan University, Shanghai 200030, China
Dong-Li He, Qi Guo, Endoscopy Center, Shanghai Xuhui Central Hospital, Shanghai 200030, China
Yan Wang, Endoscopy Center, Traditional Chinese Medical Hospital, Rongcheng 264300, Shandong Province, China
Bai-Sheng Chen, Department of Endoscopy Center, Xiamen Branch of Affiliated Zhongshan Hospital of Fudan University, Xiamen 361000, Fujian Province, China
Xue-Si Dong, Ni Li, Office of Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100000, China
Xing Li, Department of Gastroenterology, Pingxiang People’s Hospital, Pingxiang 337000, Jiangxi Province, China
Hai-Yan Huang, Department of Clinical Medicine, Xiaogang Hospital, Ningbo 315000, Zhejiang Province, China
Jian-Guang Xu, Endoscopy Center, Quzhou People’s Hospital, Quzhou 324000, Zhejiang Province, China
Jian-Min Xu, Department of General Surgery, Zhongshan Hospital of Fudan University, Shanghai 200030, China
Author contributions: Qi ZP, Xu EP and He DL contributed equally. Li N, Xu JM, Zhou PH, and Zhong YS contributed to the concept and design of the study and critical revision of the manuscript for important intellectual content; Qi ZP and Xu EP drafted the manuscript; Dong XS and Li N contributed to the statistical analysis; Zhang YS obtained funding; He DL, Xu JM, Zhou PH, and Zhong YS involved in the administrative, technical, or material support; Wang Y, Chen BS, Guo Q, and Li X contributed to the supervision of this manuscript; and all authors involved in the acquisition, analysis, or interpretation of data.
Supported by the National Key R&D Program of China, No. 2018YFC1315005; National Natural Science Foundation of China, No. 82002515; Shanghai Sailing Program, No. 20YF1407200; and China Postdoctoral Science Foundation, No. 2020M681177.
Institutional review board statement: This study was approved by the Ethics Committee of Zhongshan Hospital Fudan University (B2019-131R).
Clinical trial registration statement: This study was registered on the Chinese Clinical Trial Registry (ChiCTR1900026026).
Informed consent statement: Written informed consent was obtained from all patients.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: Technical appendix, statistical code, and dataset available from the corresponding author at zhong.yunshi@zs-hospital.sh.cn.
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 that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Yun-Shi Zhong, MD, PhD, Doctor, Surgeon, Endoscopy Center, Zhongshan Hospital of Fudan University, No. 180 Fenglin Road, Shanghai 200030, China. zhong.yunshi@zs-hospital.sh.cn
Received: December 5, 2022
Peer-review started: December 5, 2022
First decision: January 9, 2023
Revised: January 24, 2023
Accepted: April 12, 2023
Article in press: April 12, 2023
Published online: May 15, 2023
Processing time: 157 Days and 17.3 Hours
ARTICLE HIGHLIGHTS
Research background

Adenoma detection rate (ADR) as main outcome quality parameter of colonoscopy is under controversial with the use of the image-enhanced endoscopy (IEE). Although there have some randomized controlled trials (RCTs) to compare different IEE with white-light imaging (WLI), the sample is limited and there is still lacking the RCT of IEE with Asian population.

Research motivation

To compare IEE with WLI for the detection and identification of colorectal adenoma and provide the solid outcomes.

Research objectives

To compare IEE with WLI endoscopy for the detection and identification of colorectal adenoma.

Research methods

We designed a prospective, multicenter, randomized, controlled trial to compere the ADR between the IEE group and WLI group.

Research results

The ADR in two group were not significantly different [24.0% vs 21.8%,1.10, 95% confidence interval (CI): 0.99-1.23, P = 0.09]. The polyp detection rate was higher with IEE group (41.7%) than with WLI group (36.1%, 1.16, 95%CI: 1.07-1.25, P = 0.01). Differences in mean withdrawal time (7.90 ± 3.42 min vs 7.85 ± 3.47 min, P = 0.30) and adenomas per colonoscopy (0.33 ± 0.68 vs 0.28 ± 0.62, P = 0.06) were not significant. Subgroup analysis found that with narrow-band imaging (NBI), between-group differences in the ADR, were not significant (23.7% vs 21.8%, 1.09, 95%CI: 0.97-1.22, P = 0.15), but were greater with linked color imaging (30.9% vs 21.8%, 1.42, 95%CI: 1.04-1.93, P = 0.04). The second-generation NBI (2G-NBI) had an advantage of ADR than both WLI and 1G-NBI (27.0% vs 21.8%, P = 0.01; 27.0% vs 21.2.0%, P = 0.01).

Research conclusions

This prospective study confirmed that, among Chinese, IEE didn’t increase the ADR compared with WLI, but 2G-NBI increase the ADR. Colonoscopists with low ADR might consider using 2G-NBI for performance.

Research perspectives

The efficacy of various modes of IEE still needs to be verified by clinical research.