Development and clinical validation of a novel deep learning-based mediastinal endoscopic ultrasound navigation system for quality control: a single-center, randomized controlled trial

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BACKGROUND: Endoscopic ultrasound (EUS) is crucial for diagnosing and managing mediastinal diseases but lacks effective quality control. This study developed and evaluated an artificial intelligence (AI) system to assist in anatomical landmark identification and scanning guidance, aiming to improve quality control of mediastinal EUS examinations in clinical practice. METHODS: The AI system for mediastinal EUS was trained on 11 230 annotated images from 120 patients, validated internally (1972 images) and externally (824 images from three institutions). A single-center randomized controlled trial was designed to evaluate the effect of quality control, which enrolled patients requiring mediastinal EUS, randomized 1:1 to AI-assisted or control groups. Four endoscopists performed EUS, with the AI group receiving real-time AI feedback. The primary outcome was standard station completeness; secondary outcomes included structure completeness, procedure time, and adverse events. Blinded analysis ensured objectivity. RESULTS: Between 16 September 2023, and 28 February 2025, a total of 148 patients were randomly assigned and analyzed, with 72 patients in the AI-assisted group and 76 in the control group. The overall station completeness was significantly higher in the AI-assisted group than in the control group (1.00 [IQR, 1.00-1.00] vs. 0.80 [IQR, 0.60-0.80]; P < 0.001), with the AI-assisted group also demonstrating significantly higher anatomical structure completeness (1.00 [IQR, 1.00-1.00] vs. 0.85 [IQR, 0.62-0.92]; P < 0.001). However, no significant differences were found for station 2 (subcarinal area) or average procedural time, and no adverse events were reported. CONCLUSIONS: The AI system significantly improved the scan completeness and shows promise in enhancing EUS quality control.

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