Real-time Voice-Guided Artificial Intelligence Improves Biliopancreatic Endosonography Quality: A Randomized Trial

Endoscopic ultrasonography (EUS) quality is operator-dependent, and adherence to guideline-recommended multi-station biliopancreatic scanning remains suboptimal. We developed a device (named EUS-GUIDEQ), an artificial intelligence (AI)-based real-time EUS navigation and quality-control system providing station recognition, voice-guided prompts, and quantitative completeness feedback. We evaluated its performance and clinical utility.

EUS-GUIDEQ was developed from 27,072 annotated biliopancreatic EUS images obtained from 189 patients and validated on independent datasets consisting of 1,500 internal images and 2,062 multicenter external images. We then conducted a prospective, single-center, randomized controlled trial (1:1) comparing AI-assisted versus standard EUS. The primary endpoint was completeness of standardized scanning stations. Secondary endpoints included station-level and landmarks completeness, procedure duration (observation time excluding additional interventions), and adverse events. Outcomes were adjudicated by blinded expert review of recorded videos.

Station-classification model achieved accuracies of 94.2% internally and 78.8% externally. Between December 12, 2023, and May 16, 2025, 266 patients were analyzed (AI-assisted n=132; control n=134). Overall station completeness was higher with EUS-GUIDEQ assistance (median [IQR] 1.00 [0.94-1.00] vs 0.81 [0.75-0.88]; P<0.001), with benefit observed across participating endoscopists. Completeness was higher for most anatomical landmarks in nominal comparisons. Procedure time was longer with AI assistance (12.70±3.23 vs 10.55±3.62 min; P<0.001). No serious procedure-related adverse events occurred.

In a randomized trial, voice-guided real-time AI navigation improved guideline-level biliopancreatic EUS process quality, as measured by station completeness, but increased procedure time. Multicenter, multi-vendor prospective validation is warranted.