Abstract

Background: The protocol for surveillance for Esophageal Squamous Cell Carcinoma (ESCC) in China following screening lacks evidence from large-scale population-based studies. We aim to establish an evidence-based surveillance target and respective intervals for ESCC surveillance. Methods: This study enrolled 14980 subjects from a large-scale randomized controlled trial in China. Poisson regression models were applied to estimate adjusted incidence rate ratios (IRR) for subjects with Lugol-unstained lesions (LUL) of differing size and baseline pathologic diagnosis. We clustered subgroups of subjects with LULs of varying size and pathologic status into three categories (low, moderate and high risk) according to their risk of progression to ESCC. Cumulative incidence of ESCC was calculated year by year for these three categories to determine appropriate surveillance intervals. Findings: LUL size is a principal predictor of post-screening risk of ESCC besides the pathologic diagnosis (adjusted IRR 6-10 mm VS none = 8·54, 95%CI: 2·78-26·24; adjusted IRR >10 mm VS none = 30·91, 95%CI: 10·69-89·39). Subjects with LULs >10mm (irrespective of the pathologic diagnosis) had the highest risk of progression, and the risk grew rapidly after the 2 nd year following the index endoscopy. Subjects with LULs of 6-10mm (irrespective of the pathologic diagnosis) or dysplastic LULs of 1-5mm had moderate risk, and the risk started to rise after the year three. Interpretation: We propose a novel surveillance strategy for ESCC that combines Lugol’s chromoendoscopy findings and the pathologic diagnosis. Use of this strategy would improve the effectiveness of ESCC screening programs in China. Funding: This study was supported by the National Key R&D Program of China (2016YFC0901404) and the National Natural Science Foundation of China (81773501). Declaration of Interests: The authors declare that they have no competing interests. Ethics Approval Statement: Research protocols were approved by the Institutional Review Board of Peking University School of Oncology.

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