Effect of an Endoscopy Screening on Upper Gastrointestinal Cancer Mortality: A Community-based Multicenter Cluster Randomized Clinical Trial

Changfa Xia; He Li; Yongjie Xu; Guizhou Guo; Xiaodong Yu; Wanying Wang; Shuguang Dai; Chunyun Dai; Yigong Zhu; Kun Jiang; Zhiyi Zhang; Junguo Hu; Guohui Song; Chao Chen; Haifan Xiao; Yanfang Chen; Ting Song; Shipeng Yan; Bingbing Song; Yutong He; Jinyi Zhou; Shaokai Zhang; Wanqing Chen

doi:10.1053/j.gastro.2024.11.025

Effect of an Endoscopy Screening on Upper Gastrointestinal Cancer Mortality: A Community-based Multicenter Cluster Randomized Clinical Trial

Gastroenterology. 2024 Dec 18:S0016-5085(24)05789-5. doi: 10.1053/j.gastro.2024.11.025. Online ahead of print.

Authors

Changfa Xia¹, He Li², Yongjie Xu¹, Guizhou Guo³, Xiaodong Yu³, Wanying Wang⁴, Shuguang Dai⁵, Chunyun Dai⁵, Yigong Zhu⁶, Kun Jiang⁶, Zhiyi Zhang⁷, Junguo Hu⁷, Guohui Song⁸, Chao Chen⁸, Haifan Xiao⁹, Yanfang Chen¹⁰, Ting Song¹⁰, Shipeng Yan⁹, Bingbing Song⁴, Yutong He¹¹, Jinyi Zhou¹², Shaokai Zhang¹³, Wanqing Chen¹⁴

Affiliations

¹ Office of Cancer Screening, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
² Office of National Cancer Regional Medical Centre in Liaoning Province, The First Affiliated Hospital of China Medical University, Shenyang 110001, China.
³ Linzhou Institute for Cancer Prevention and Control, Linzhou Cancer Hospital, Linzhou 456500, China.
⁴ Heilongjiang Office for Cancer Control and Research, Harbin Medical University Cancer Hospital, Harbin 150081, China.
⁵ Department for Chronic Non-communicable Diseases Control, Center for Disease Control and Prevention of Sheyang County, Yancheng 224300, China.
⁶ Department for Chronic Non-communicable Diseases Control, Luoshan Center for Disease Control and Prevention, Xinyang 464299, China.
⁷ Department of Public Health, Gansu Wuwei Tumor Hospital, Wuwei 733000, China.
⁸ Cixian Institute for Cancer Prevention and Control, Cixian Cancer Hospital, Handan 056500, China.
⁹ Hunan Office for Cancer Control and Research, Hunan Cancer Hospital, Changsha 410006, China.
¹⁰ Department for Chronic Non-communicable Diseases Control, Yueyang Lou District Center for Disease Prevention and Control, Yueyang 414021, China.
¹¹ Cancer Institute, the Fourth Hospital of Hebei Medical University/the Tumor Hospital of Hebei Province, Shijiazhuang 050011, China.
¹² Department for Chronic Non-communicable Diseases Control, Jiangsu Provincial Centre for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province), Nanjing 210009, China.
¹³ Henan Office for Cancer Control and Research, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou 450008, China.
¹⁴ Office of Cancer Screening, National Cancer Centre/National Clinical Research Centre for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China. Electronic address: chenwq@cicams.ac.cn.

PMID: 39706350
DOI: 10.1053/j.gastro.2024.11.025

Abstract

Background and aims: Population-based observational studies suggest that endoscopic screening may reduce upper gastrointestinal cancer mortality. We aimed to quantify the effect of endoscopy screening.

Methods: This is a community-based, multicenter, cluster randomized clinical trial conducted in both high-risk and non-high-risk areas of China. Randomization and recruitment occurred between 2015 and 2017, with follow-up conducted until 2022. The intervention was an invitation to receive endoscopic screening, as opposed to receiving usual-care (unscreened). In non-high-risk areas, only participants assessed as high-risk by risk scores in the screening group were invited for endoscopic screening. The primary outcome was the cumulative risk of death from upper gastrointestinal cancer, adjusted for baseline characteristics and cluster effects.

Results: A total of 234,635 participants were included in the intention-to-screen analysis, with median age of 52 years. In high-risk areas, 64,836 individuals from 81 clusters were randomized to screening group, 59,379 individuals from 82 clusters were randomized to control group. In non-high-risk areas, 58,367 individuals from 92 clusters were randomized to screening group, 52,053 individuals from 90 clusters were randomized to control group. Among high-risk areas, 480 (adjusted cumulative risk, 0.77%) died of upper gastrointestinal cancers within 7.5 years in screening group vs 545 (0.99%) deaths in control group (risk ratio, 0.78; 95% CI, 0.66-0.91). Among non-high-risk areas, adjusted risk was 0.26% (146 deaths) in screening group and 0.30% (149 deaths) in control group (risk ratio, 0.86; 95% CI, 0.65-1.13).

Conclusions: An invitation to endoscopic screening reduced upper gastrointestinal cancer mortality in high-risk areas. In non-high-risk areas, an invitation to endoscopic screening based on risk scores did not significantly decrease upper gastrointestinal cancer deaths, but longer follow-up time was required.

Keywords: Cancer screening; Clinical trial; Endoscopy; Gastrointestinal neoplasms; Public health.