Abstract
BACKGROUND: Chromoendoscopy has not been fully integrated into capsule endoscopy. This study aimded to develop and validate a novel intelligent chromo capsule endoscope (ICCE). METHODS: The ICCE has two modes: a white-light imaging (WLI) mode and an intelligent chromo imaging (ICI) mode. The performance of the ICCE in observing colors, animal tissues, and early gastrointestinal (GI) neoplastic lesions in humans was evaluated. Images captured by the ICCE were analysed using variance of Laplacian (VoL) values or image contrast evaluation. RESULTS: For color observation, conventional narrow-band imaging endoscopes and the ICI mode of the ICCE have similar spectral distributions. Compared with the WLI mode, the ICI mode had significantly higher VoL values for animal tissues (2.154 ± 1.044 vs 3.800 ± 1.491, P = 0.003), gastric precancerous lesions and early gastric cancers (2.242 ± 0.162 vs 6.642 ± 0.919, P < 0.001), and colon tumors (3.896 ± 1.430 vs 11.882 ± 7.663, P < 0.001), and significantly higher contrast for differentiating tumor and non-tumor areas (0.069 ± 0.046 vs 0.144 ± 0.076, P = 0.005). More importantly, the sensitivity, specificity, and accuracy of the ICI mode for early GI tumors were 95.83%, 91.67%, and 94.64%, respectively, which were significantly higher than the values of the WLI mode (78.33% [P < 0.001], 77.08% [P = 0.01], and 77.98% [P < 0.001], respectively). CONCLUSIONS: We successfully integrated ICI into the capsule endoscope. The ICCE is an innovative and useful tool for differential diagnosis based on contrast-enhanced images and thus has great potential as a superior diagnostic tool for early GI tumor detection.