Initial results from a multi-center population-based cluster randomized trial of esophageal and gastric cancer screening
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RESEARCH ARTICLE
Open Access
Initial results from a multi‑center population‑based cluster randomized trial of esophageal and gastric cancer screening in China Hongmei Zeng1, Kexin Sun1, Maomao Cao2, Rongshou Zheng1, Xibin Sun3, Shuzheng Liu3, Zhiyi Zhang4, Yuqin Liu5, Guizhou Guo6, Guohui Song7, Yigong Zhu8, Xianghong Wu9, Bingbing Song10, Xianzhen Liao11, Yanfang Chen12, Mingyang Song13,14,15,16, Edward Giovannucci13,14, Guihua Zhuang17, Wenqiang Wei1, Wanqing Chen2* and Jie He18
Abstract Background: We initiated the first multi-center cluster randomized trial of endoscopic screening for esophageal cancer and gastric cancer in China. The objective of the study was to report the baseline screening findings in this trial. Methods: We recruited a total of 345 eligible clusters from seven screening centers. In the intervention group, participants from high-risk areas were screened by endoscopy; in non-high-risk areas, high-risk individuals were identified using a questionnaire and advised for endoscopy. Lugol’s iodine staining in esophagus and indigo carmine dye in stomach were performed to aid in the diagnosis of suspicious lesions. The primary outcomes of this study were the detection rate (proportion of positive cases among individuals who underwent endoscopic screening) and early detection rate (the proportion of positive cases with stage 0/I among all positive cases). Results: A total of 149,956 eligible subjects were included. The detection rate was 0.7% in esophagus and 0.8% in stomach, respectively. Compared with non-high-risk areas, the detection rates in high-risk areas were higher, both in esophagus (0.9% vs. 0.1%) and in stomach (0.9% vs. 0.3%). The same difference was found for early-detection rate (esophagus: 92.9% vs. 53.3%; stomach: 81.5% vs. 33.3%). Conclusions: The diagnostic yield of both esophagus and stomach were higher in high-risk areas than in non-highrisk areas, even though in non-high-risk areas, only high-risk individuals were screened. Our study may provide important clues for evaluating and improving the effectiveness of upper-endoscopic screening in China. Trial registration: Protocol Registration System in Chinese Clinical Trial Registry, ChiCTR-EOR-16008577. Registered 01 June 2016-Retrospectively registered, http://www.chictr.org.cn/showprojen.aspx?proj=14372 Keywords: Esophageal cancer, Gastric cancer, Endoscopic screening, Trial, China
*Correspondence: [email protected] 2 Office for Cancer Screening, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 South Lane, Panjiayuan, Chaoyang District, Beijing 100021, China Full list of author information is available at the end of the article
Background China is a high-risk country for esophageal cancer (EC) and gastric cancer (GC), accounting for about 50% (763,483 new cases, 673,615 deaths in 2018) of the global burden [1]. Most EC and GC cases present in advanced stages and the overall 5-year survival is low. Early
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