Non-invasive capsule sponge with AI cytology shows promise for screening high-risk areas of China

Results from a study of 1,844 participants from a high-risk area in China indicate that esopphageal cells captured non-invasively via a capsule sponge, when combined with a trained artificial intelligence (AI) system can substantially reduce the need for endoscopy with histopathology, with a sensitivity of 93.7% and positive predictive value of 13.5%.

Am J Gastroenterol. 2021 Nov 1;116(11):2207-2215. doi: 10.14309/ajg.0000000000001499.

Feasibility and Accuracy of Artificial Intelligence-Assisted Sponge Cytology for Community-Based Esophageal Squamous Cell Carcinoma Screening in China

Ye Gao 1, Lei Xin 1, Ya-Dong Feng 2, Bin Yao 3 4, Han Lin 1, Chang Sun 1, Wei An 1, Zhao-Shen Li 1, Rui-Hua Shi 2, Luo-Wei Wang 1

PMID: 34546186 DOI: 10.14309/ajg.0000000000001499

Abstract

Introduction: Screening is the pivotal strategy to relieve the burden of esophageal squamous cell carcinoma (ESCC) in high-risk areas. The cost, invasiveness, and accessibility of esophagogastroduodenoscopy (EGD) necessitate the development of preliminary screening methods.

Methods: Residents aged 40-85 years were recruited in a high-risk area of ESCC. Esophageal cells were collected using an approved novel capsule sponge, and cytology slides were scanned by a trained artificial intelligence (AI) system before cytologists provided confirmation. Atypical squamous cell or more severe diagnosis was defined as positive cytology. AI-based abnormal cell counts were also reported. EGD was performed subsequently with biopsy as needed. Diagnostic accuracy, adverse events, and acceptability of cytology testing were assessed. Esophageal high-grade lesions (ESCC and high-grade intraepithelial neoplasia) were the primary target lesions.

Results: In total, 1,844 participants were enrolled, and 20 (1.1%) high-grade lesions were confirmed by endoscopic biopsy. The AI-assisted cytologist-confirmed cytology showed good diagnostic accuracy, with a sensitivity of 90.0% (95% confidence interval [CI], 76.9%-100.0%), specificity of 93.7% (95% CI, 92.6%-94.8%), and positive predictive value of 13.5% (95% CI, 7.70%-19.3%) for detecting high-grade lesions. The area under the receiver operation characteristics curve was 0.926 (95% CI, 0.850-1.000) and 0.949 (95% CI, 0.890-1.000) for AI-assisted cytologist-confirmed cytology and AI-based abnormal cell count, respectively. The numbers of EGD could be reduced by 92.5% (from 99.2 to 7.4 to detect 1 high-grade lesion) if only cytology-positive participants were referred to endoscopy. No serious adverse events were documented during the cell collection process, and 96.1% participants reported this process as acceptable.

Discussion: The AI-assisted sponge cytology is feasible, safe, and acceptable for ESCC screening in community, with high accuracy for detecting esophageal squamous high-grade lesions.

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