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Randomized Controlled Trial
. 2020 Nov 24;20(1):398.
doi: 10.1186/s12876-020-01517-3.

Initial results from a multi-center population-based cluster randomized trial of esophageal and gastric cancer screening in China

Hongmei Zeng  1 , Kexin Sun  1 , Maomao Cao  2 , Rongshou Zheng  1 , Xibin Sun  3 , Shuzheng Liu  3 , Zhiyi Zhang  4 , Yuqin Liu  5 , Guizhou Guo  6 , Guohui Song  7 , Yigong Zhu  8 , Xianghong Wu  9 , Bingbing Song  10 , Xianzhen Liao  11 , Yanfang Chen  12 , Mingyang Song  13   14   15   16 , Edward Giovannucci  13   14 , Guihua Zhuang  17 , Wenqiang Wei  1 , Wanqing Chen  18 , Jie He  19
Affiliations
Randomized Controlled Trial

Initial results from a multi-center population-based cluster randomized trial of esophageal and gastric cancer screening in China

Hongmei Zeng et al. BMC Gastroenterol. .

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-high-risk 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: China; Endoscopic screening; Esophageal cancer; Gastric cancer; Trial.

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Conflict of interest statement

The authors have declared no conflicts of interest.

Figures

Fig. 1
Fig. 1
Flow diagram of the participants in the multi-center randomized trial, overall and by areas: a Overall. b High-risk areas. c Non-high-risk areas
Fig. 1
Fig. 1
Flow diagram of the participants in the multi-center randomized trial, overall and by areas: a Overall. b High-risk areas. c Non-high-risk areas
Fig. 2
Fig. 2
The detection rates of participants in high-risk areas and non-high-risk areas
See this image and copyright information in PMC

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