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Magnifying image-enhanced endoscopy–only mode boosted early cancer diagnostic efficiency: a multicenter randomized controlled trial - 16/11/23

Doi : 10.1016/j.gie.2023.06.068 
Ai-Rui Jiang, MD 1, 2, , Li-Ming Wen, MD, PhD 3, , Jian-Wei Ding, MD 4, , Rui-Zheng Zou, MD 5, , Xu-Biao Nie, MD 1, Hui Lin, MD 1, 6, Jing Chen, MD 7, Wei-Sen Zhang, MD 8, Liang-Ying Dan, MD 4, Yu-Xia Zhu, MD 5, Chun-Mei Ren, MD 3, Ying-Yang Wu, MD 1, Lin-Lin Sheng, MD 1, Ding-Rong Chen, MD 1, Guo-Bin Liao, MD 1, 9, Hai-Yan Zhao, MD 1, Jian-Jun Li, MD 1, Ying Zuo, MD 1, Jie Chen, MD 1, Jian-Ying Bai, MD, PhD 1, , Liang-Bi Xu, MD, PhD 8, Shuang Yu, MD, PhD 7
1 Department of Gastroenterology, the Second Affiliated Hospital, Army Medical University, Chongqing, China 
2 Department of Gastroenterology, The People’s Hospital of Wansheng District, Chongqing, China 
3 Department of Gastroenterology, Sichuan MianYang 404 Hospital, Sichuan, China 
4 Department of Gastroenterology, The People’s Hospital of Tongliang District, Chongqing, China 
5 Department of Gastroenterology, The People's Hospital of Chongqing LiangJiang New Area, Chongqing, China 
6 Department of Epidemiology, Army Medical University, Chongqing, China 
7 Department of Gastroenterology, Chongqing University Three Gorges Hospital, Chongqing, China 
8 Department of Gastroenterology, The Affiliated Hospital of Guizhou Medical University, Guizhou, China 
9 Department of Gastroenterology, The 901 Hospital of Chinese People's Liberation Army Joint Service Support Unit, Hefei, China 

Reprint requests: Jian-Ying Bai, MD, PhD, Department of Gastroenterology, the Second Affiliated Hospital, Army Medical University, 83 Xinqiao Main St, Shapingba District, Chongqing 400037, China.Department of Gastroenterologythe Second Affiliated HospitalArmy Medical UniversityShapingba DistrictChongqingMD400037China

Abstract

Background and Aims

Magnifying image-enhanced endoscopy (MIEE) is an advanced endoscopy with image enhancement and magnification used in preoperative examination. However, its impact on the detection rate is unknown.

Methods

We conducted an open-label, randomized, parallel (1:1:1), controlled trial in 6 hospitals in China. Patients were recruited between February 14, 2022 and July 30, 2022. Eligible patients were aged ≥18 years and undergoing gastroscopy in outpatient departments. Participants were randomly assigned to the MIEE-only mode (o-MIEE) group, white-light endoscopy–only mode (o-WLE) group, and MIEE when necessary mode (n-MIEE) group (initial WLE followed by switching to another endoscope with MIEE if necessary). Biopsy sampling of suspicious lesions of the lesser curvature of the gastric antrum was performed. Primary and secondary aims were to compare detection rates and positive predictive value (PPV) of early cancer and precancerous lesions in these 3 modes, respectively.

Results

A total of 5100 recruited patients were randomly assigned to the o-MIEE (n = 1700), o-WLE (n = 1700), and n-MIEE (n = 1700) groups. In the o-MIEE, o-WLE, and n-MIEE groups, 29 (1.51%; 95% confidence interval [CI], 1.05-2.16), 4 (.21%; 95% CI, .08-.54), and 8 (.43%; 95% CI, .22-.85) early cancers were found, respectively (P < .001). The PPV for early cancer was higher in the o-MIEE group compared with the o-WLE and n-MIEE groups (63.04%, 33.33%, and 38.1%, respectively; P = .062). The same trend was seen for precancerous lesions (36.67%, 10.00%, and 21.74%, respectively).

Conclusions

The o-MIEE mode resulted in a significant improvement in diagnosing early upper GI cancer and precancerous lesions; thus, it could be used for opportunistic screening. (Clinical trial registration number: ChiCTR2200064174.)

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Abbreviations : CI, IEE, MIEE, n-MIEE, o-MIEE, o-WLE, PPV, UGI, WLE


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 DIVERSITY, EQUITY, AND INCLUSION: We worked to ensure gender balance in the recruitment of human subjects. We worked to ensure ethnic or other types of diversity in the recruitment of human subjects. We worked to ensure that the language of the study questionnaires reflected inclusion. While citing references scientifically relevant for this work, we actively worked to promote gender balance in our reference list. The author list of this paper includes contributors from the location where the research was conducted who participated in the data collection, design, analysis, and/or interpretation of the work.
 Jian-Ying Bai, Liang-Bi Xu, and Shuang Yu share senior co-corresponding authorship.


© 2023  American Society for Gastrointestinal Endoscopy. Pubblicato da Elsevier Masson SAS. Tutti i diritti riservati.
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