Prospective clinical validation of a novel artificial intelligence system for real-time detection of solid pancreatic masses during endoscopic ultrasonography.

Journal: Endoscopy
Published Date: Sep 15, 2025

Abstract

Endoscopic ultrasonography (EUS) is the most sensitive modality for accurately establishing a tissue diagnosis in patients with solid pancreatic masses. However, small lesions can be challenging to detect, particularly for less experienced endosonographers. Therefore, outcomes of EUS are operator dependent. We validated the performance of novel artificial intelligence (AI)-enhanced EUS for detection of solid pancreatic lesions.In this single-center, prospective, nonrandomized, comparative study, high-risk patients aged ≥18 years referred for pancreatic cancer screening or with suspected (solid and cystic) pancreatic lesions owing to symptoms, radiological, or laboratory findings were evaluated in real time using AI-EUS software. The model included 32 713 EUS frames (training/testing phases) of normal, solid, and >10-mm cystic pancreatic lesions from 202 patients. Clinical validation was conducted prospectively when EUS findings were evaluated concurrently in real time by two independent expert examiners, one using conventional EUS and another with AI-EUS, both blinded to the alternative assessments. The primary outcome was detection of solid pancreatic masses.308 patients were evaluated (January-July 2024). AI-EUS performance was not significantly different to that of conventional EUS performed by experts (97.1% vs. 100%; risk difference 2.9%, 95%CI -1.2 to 6.8; P = 0.25). Final pathology of 105 pancreatic solid masses revealed neoplasia in 93 (88.6%) and benign lesions in 12 (11.4%).The performance of AI-EUS was not significantly different to that of experienced endosonographers for detection and segmentation of solid pancreatic masses. By standardizing performance, AI-EUS may have the potential to optimize clinical outcomes in pancreatic cancer.

Authors

  • Ji Young Bang
    Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, USA.
  • Adrian Săftoiu
    Research Center of Gastroenterology and Hepatology, University of Medicine and Pharmacy Craiova, Romania. [email protected].
  • Anca Udriștoiu
    Automation, Computers and Electronics, University of Craiova, Craiova, Romania.
  • Lucian Gruionu
    Faculty of Mechanics, University of Craiova, Craiova, Romania.
  • Elena Codruța Gheorghe
    Gastroenterology and Hepatology, University of Medicine and Pharmacy of Craiova, Craiova, Romania.
  • Gabriel Gruionu
    Faculty of Mechanics, University of Craiova, Craiova, Romania. [email protected].
  • Jayapal Ramesh
    Digestive Health Institute, Orlando Health, Orlando, United States.
  • Charles Melbern Wilcox
    Digestive Health Institute, Orlando Health, Orlando, United States.
  • Shyam Varadarajulu
    Center for Interventional Endoscopy, AdventHealth, Orlando, Florida, USA.

Keywords

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