Objective Description of the design and preliminary results of baseline recruitment and screening in the endoscopic screening for esophageal cancer in China (ESECC), the first randomised controlled trial (RCT) assessing efficacy and cost-effectiveness of endoscopic screening for esophageal squamous cell carcinoma (ESCC).
Design ESECC trial is a cluster RCT, and 668 villages in rural Hua County, Henan Province, a high-incidence area of ESCC in China, were randomised into two arms at a ratio of 1:1. Screening arm participants were screened by Lugol chromoendoscopy; no screening was performed in the control arm. ESCC-specific and all-cause mortality, incidence of advanced ESCC and cost-effectiveness of screening will be evaluated in the next 10-year follow-up. Here, we report the performance of baseline recruitment and randomisation, prevalence of upper GI lesions and risk factors for ESCC.
Results A total of 17 151 and 16 797 participants were enrolled in screening and control arms from January 2012 to September 2016. The truncated prevalence (aged 45–69 years) of oesophageal and overall upper GI high-grade lesions was 744.0/100 000 and 902.0/100 000. 69.9% of the 113 patients with high-grade oesophageal lesions were of early stage. Risk factors for severe oesophageal dysplasia and more severe lesions in this population included higher age, family history of ESCC, lower body mass index, eating rapidly and frequent ingestion of leftovers.
Conclusion This ESECC trial met the predesigned recruitment and randomisation requirements. Age, family history, undernutrition and unhealthy dietary habits increased the risk for high-grade oesophageal lesions in this high-risk population.
Trail registration number NCT01688908; Pre-results.
- esophageal squamous cell carcinoma
- population-based screening
- randomized control trial
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ZH, ZL and ML contributed equally.
Contributors Study concept and design: YK, HC and ZH; acquisition of data: ZH, ZL, ML, CG, RX, FL, AL, HY, LS, QW, LD, XL, CZ and YP; analysis and interpretation of data: ZL, ZH, ML, HC and YK; drafting of the manuscript: ZH, ZL, ML, HC and YK; statistical analysis: ZH, ZL and ML; study supervision: ZH, HC and YK.
Funding This work was supported by the charity project of the national ministry of health (grant number 201202014), the natural science foundation of China (grant number 30930102, 81473033, 81773501), the natural science foundation of Beijing (grant number 7100001), the '973' project of national ministry of science and technology (grant number 2011CB504300), the UMHS-PUHSC joint institute for translational and clinical research (grant number BMU20140483), the national key R&D programme of China (grant number 2016YFC0901404), the science foundation of Peking University Cancer Hospital (grant number 2017-4) and the open project funded by the Key Laboratory of Carcinogenesis and Translational Research, Ministry of Education/Beijing (grant number 2017-10).
Competing interests None declared.
Patient consent Obtained.
Ethics approval This trial was approved by the Institutional Review Board of the Peking University School of Oncology, China.
Provenance and peer review Not commissioned; externally peer reviewed.
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