Effect of a Computer-Aided Device for Detecting Gastric Neoplasms: A Multicenter, Randomized Controlled Trial

Zehua Dong¹, Lianlian Wu¹, Hongliu Du¹, Xiao Tao¹, Junxiao Wang¹, Xiaoquan Zeng¹, Yijie Zhu², Shuzhe Tan¹, Jiamin Wang¹, Mei Deng¹, Ting Yang¹, Chen Chen³, Liming Wen⁴, Ying Li⁵, Congyao Jiang⁶, Chuang Tang⁷, Yulin Wang⁸, Zhifeng Zhao⁹, Qinghua Wang¹⁰, Haodong Yu¹¹, Chaoyuan Chen¹², Yaowei Ai¹³, Jie Pan¹⁴, Fengsong Chen¹⁵, Qiang Guo², Xinli Mao¹⁶, Junhong Li¹⁷, Huifang Pang¹⁸, Jianyu Hao¹⁹, Yan Jiao²⁰, Qizhi Wang²¹, Heng Zhang²², Shicai Ye²³, Tong Dang²⁴, Liangliang Yu²⁵, Shan Hu²⁶, Wei Zhou¹, Yunchao Deng¹, Yanxia Li¹, Boru Chen¹, Bing Xiao¹, Jun Liu¹, Jiamin Qin⁴, Ting Zhang⁷, Tong Bu⁹, Jiayi Shi¹⁰, Yumei Wang¹¹, Hong Zhang¹², Jiejun Lin¹⁴, Lei Jin¹⁸, Jianfeng Yu¹⁹, Bofu Tang²⁴, Xia Tan¹, Lilei Yu²⁷, Honggang Yu²⁸

Affiliations

¹ Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease, Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Engineering Research Center for Artificial Intelligence Endoscopy Interventional Treatment of Hubei Province, Wuhan, China.
² Department of Gastroenterology, The First People's Hospital of Yunnan Province, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, China.
³ Department of Global Health, School of Public Health, Wuhan University, Wuhan, China.
⁴ Department of Gastroenterology, Sichuan Mianyang 404 Hospital, Mianyang, China.
⁵ Digestive Endoscopy Center, Wuhan Eighth Hospital, Wuhan, China.
⁶ Department of Gastroenterology, Zigui County People's Hospital, Yichang, China.
⁷ Department of Gastroenterology, West China (Airport) Hospital, Sichuan University, The First People's Hospital of Shuangliu District, Sichuan, China.
⁸ Digestion Medicine Department, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China.
⁹ Department of Gastroenterology, The Fourth Affiliated Hospital of China Medical University, Shenyang, China.
¹⁰ Department of Gastroenterology, Kunshan First People's Hospital Affiliated to Jiangsu University, Kunshan, China.
¹¹ Department of Gastroenterology, Qianjiang Central Hospital of Chongqing, Chongqing, China.
¹² Fujian Provincial People's Hospital, Department of Gastroenterology, Fuzhou, China.
¹³ Department of Gastroenterology, Yichang Central People's Hospital, Yichang, China.
¹⁴ Department of Gastroenterology, The Dingli Clinical College of Wenzhou Medical University (Wenzhou Central Hospital), Wenzhou, China.
¹⁵ Department of Gastroenterology, Haimen People's Hospital, Nantong, China.
¹⁶ Department of Gastroenterology, Taizhou Hospital of Zhejiang Province, affiliated to Wenzhou Medical University, Linhai, China.
¹⁷ Department of Gastroenterology, Shenzhen Samii International Medical Center, Shenzhen, China.
¹⁸ Department of Gastroenterology, Tongliao People's Hospital, Tongliao, China.
¹⁹ Department of Gastroenterology, Beijing Chaoyang Hospital, Capital Medical 23 University, Beijing, China.
²⁰ Department of Gastroenterology, Tongshan People's Hospital, Xianning, China.
²¹ Department of Gastroenterology, Xianfeng County People's Hospital, Enshi, China.
²² Department of Gastroenterology, the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
²³ Department of Gastroenterology, The Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.
²⁴ Inner Mongolia Institute of Digestive Diseases, The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, China.
²⁵ Department of Gastroenterology, Endoscopy Center, Sir Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
²⁶ School of Computer Science, Wuhan University, Wuhan, China.
²⁷ Department of Internal Medicine, Renmin Hospital of Wuhan University, Wuhan, China. Electronic address: lileiyu@whu.edu.cn.
²⁸ Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease, Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Engineering Research Center for Artificial Intelligence Endoscopy Interventional Treatment of Hubei Province, Wuhan, China. Electronic address: yuhonggang@whu.edu.cn.

PMID: 41801173
DOI: 10.1053/j.gastro.2025.12.020

Effect of a Computer-Aided Device for Detecting Gastric Neoplasms: A Multicenter, Randomized Controlled Trial

Zehua Dong et al. Gastroenterology. 2026.

. 2026 Mar 9:S0016-5085(25)06661-2.

doi: 10.1053/j.gastro.2025.12.020. Online ahead of print.

Authors

Affiliations

¹ Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease, Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Engineering Research Center for Artificial Intelligence Endoscopy Interventional Treatment of Hubei Province, Wuhan, China.
² Department of Gastroenterology, The First People's Hospital of Yunnan Province, The Affiliated Hospital of Kunming University of Science and Technology, Kunming, China.
³ Department of Global Health, School of Public Health, Wuhan University, Wuhan, China.
⁴ Department of Gastroenterology, Sichuan Mianyang 404 Hospital, Mianyang, China.
⁵ Digestive Endoscopy Center, Wuhan Eighth Hospital, Wuhan, China.
⁶ Department of Gastroenterology, Zigui County People's Hospital, Yichang, China.
⁷ Department of Gastroenterology, West China (Airport) Hospital, Sichuan University, The First People's Hospital of Shuangliu District, Sichuan, China.
⁸ Digestion Medicine Department, Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital, Tianjin, China.
⁹ Department of Gastroenterology, The Fourth Affiliated Hospital of China Medical University, Shenyang, China.
¹⁰ Department of Gastroenterology, Kunshan First People's Hospital Affiliated to Jiangsu University, Kunshan, China.
¹¹ Department of Gastroenterology, Qianjiang Central Hospital of Chongqing, Chongqing, China.
¹² Fujian Provincial People's Hospital, Department of Gastroenterology, Fuzhou, China.
¹³ Department of Gastroenterology, Yichang Central People's Hospital, Yichang, China.
¹⁴ Department of Gastroenterology, The Dingli Clinical College of Wenzhou Medical University (Wenzhou Central Hospital), Wenzhou, China.
¹⁵ Department of Gastroenterology, Haimen People's Hospital, Nantong, China.
¹⁶ Department of Gastroenterology, Taizhou Hospital of Zhejiang Province, affiliated to Wenzhou Medical University, Linhai, China.
¹⁷ Department of Gastroenterology, Shenzhen Samii International Medical Center, Shenzhen, China.
¹⁸ Department of Gastroenterology, Tongliao People's Hospital, Tongliao, China.
¹⁹ Department of Gastroenterology, Beijing Chaoyang Hospital, Capital Medical 23 University, Beijing, China.
²⁰ Department of Gastroenterology, Tongshan People's Hospital, Xianning, China.
²¹ Department of Gastroenterology, Xianfeng County People's Hospital, Enshi, China.
²² Department of Gastroenterology, the Central Hospital of Wuhan, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
²³ Department of Gastroenterology, The Affiliated Hospital of Guangdong Medical University, Zhanjiang, China.
²⁴ Inner Mongolia Institute of Digestive Diseases, The Second Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology, Baotou, China.
²⁵ Department of Gastroenterology, Endoscopy Center, Sir Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China.
²⁶ School of Computer Science, Wuhan University, Wuhan, China.
²⁷ Department of Internal Medicine, Renmin Hospital of Wuhan University, Wuhan, China. Electronic address: lileiyu@whu.edu.cn.
²⁸ Department of Gastroenterology, Renmin Hospital of Wuhan University, Wuhan, China; Hubei Provincial Clinical Research Center for Digestive Disease, Minimally Invasive Incision, Renmin Hospital of Wuhan University, Wuhan, China; Key Laboratory of Hubei Province for Digestive System Disease, Renmin Hospital of Wuhan University, Wuhan, China; Engineering Research Center for Artificial Intelligence Endoscopy Interventional Treatment of Hubei Province, Wuhan, China. Electronic address: yuhonggang@whu.edu.cn.

PMID: 41801173
DOI: 10.1053/j.gastro.2025.12.020

Abstract

Background & aims: Evidence about the effect of artificial intelligence (AI) on upper endoscopy in multicenter, randomized controlled trials is lacking. We aimed to explore whether AI can enhance gastric neoplasm detection.

Methods: Participants from 24 hospitals in China from December 21, 2021, to November 11, 2023, were randomized to AI-assisted or nonassisted esophagogastroduodenoscopy. Primary outcome was detection rate of gastric neoplasms after pathologic review. Secondary outcomes included detection rate of gastric neoplasms before review, relative early gastric cancer detection ratio, detection rate of intestinal metaplasia and/or gastric atrophy before or after review, biopsy rate, number of blind spots, and procedure/inspection time. We did intention-to-treat (ITT), per-protocol, and exploratory subgroup analysis.

Results: In the ITT cohort, 29,514 patients were enrolled. AI did not improve detection rate of gastric neoplasm after pathological review (RR, 1.13; 0.92-1.38; 1.42 vs 1.25%; P = .25). However, based on original pathology, an improvement with AI was observed (RR, 1.14; 1.0-1.28; 4.06 vs 3.57%; P = .03). AI reduced blind spots number from 2.52 to 1.07 (P < .001) and prolonged procedure and inspection time. No significant differences were observed for relative early gastric cancer detection ratio or detection rate of intestinal metaplasia and/or gastric atrophy before/after pathologic review in ITT cohort. Subgroup analysis suggested potential benefit among less experienced endoscopists and during fatigue periods. In the experimental group, AI diagnosed 100%, 91.9%, and 57.1% of pathologically confirmed gastric adenocarcinoma, high-grade, and low-grade intraepithelial neoplasia, respectively.

Conclusions: AI did not improve the detection rate of gastric neoplasms. Further real-world studies are needed to fully address the adaptability of AI. (Chinese Clinical Trial Registry, ChiCTR2100054449.).

Keywords: Artificial Intelligence; Esophagogastroduodenoscopy; Gastric Neoplasms.

PubMed Disclaimer

Save citation to file

Email citation

Add to Collections

Add to My Bibliography

Your saved search

Create a file for external citation management software

Your RSS Feed

Effect of a Computer-Aided Device for Detecting Gastric Neoplasms: A Multicenter, Randomized Controlled Trial

Affiliations

Effect of a Computer-Aided Device for Detecting Gastric Neoplasms: A Multicenter, Randomized Controlled Trial

Authors

Affiliations

Abstract