Clinical Decision Support System for All Stages of Gastric Carcinogenesis in Real-Time Endoscopy: Model Establishment and Validation Study.

Background: Our research group previously established a deep-learning-based clinical decision support system (CDSS) for real-time endoscopy-based detection and classification of gastric neoplasms. However, preneoplastic conditions, such as atrophy and intestinal metaplasia (IM) were not taken into account, and there is no established model that classifies all stages of gastric carcinogenesis.

Objective: This study aims to build and validate a CDSS for real-time endoscopy for all stages of gastric carcinogenesis, including atrophy and IM.

Methods: A total of 11,868 endoscopic images were used for training and internal testing. The primary outcomes were lesion classification accuracy (6 classes: advanced gastric cancer, early gastric cancer, dysplasia, atrophy, IM, and normal) and atrophy and IM lesion segmentation rates for the segmentation model. The following tests were carried out to validate the performance of lesion classification accuracy: (1) external testing using 1282 images from another institution and (2) evaluation of the classification accuracy of atrophy and IM in real-world procedures in a prospective manner. To estimate the clinical utility, 2 experienced endoscopists were invited to perform a blind test with the same data set. A CDSS was constructed by combining the established 6-class lesion classification model and the preneoplastic lesion segmentation model with the previously established lesion detection model.

Results: The overall lesion classification accuracy (95% CI) was 90.3% (89%-91.6%) in the internal test. For the performance validation, the CDSS achieved 85.3% (83.4%-97.2%) overall accuracy. The per-class external test accuracies for atrophy and IM were 95.3% (92.6%-98%) and 89.3% (85.4%-93.2%), respectively. CDSS-assisted endoscopy showed an accuracy of 92.1% (88.8%-95.4%) for atrophy and 95.5% (92%-99%) for IM in the real-world application of 522 consecutive screening endoscopies. There was no significant difference in the overall accuracy between the invited endoscopists and established CDSS in the prospective real-clinic evaluation (P=.23). The CDSS demonstrated a segmentation rate of 93.4% (95% CI 92.4%-94.4%) for atrophy or IM lesion segmentation in the internal testing.

Conclusions: The CDSS achieved high performance in terms of computer-aided diagnosis of all stages of gastric carcinogenesis and demonstrated real-world application potential.