RecruitingNCT07381192

An Artificial Intelligence System for Multimodal, Multi-class Diagnosing Solid Pancreatic Lesions Based on Endoscopic Ultrasound


Sponsor

Qilu Hospital of Shandong University

Enrollment

383 participants

Start Date

Sep 1, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

The aim of this study is to validate an artificial intelligence system named iEUS-SPL(intelligent endoscopic ultrasound system-solid pancreatic lesion) for detecting and multimodal, multi-class diagnosing solid pancreatic lesions during endoscopic ultrasound(EUS) examination.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Patients aged ≥18 years scheduled for EUS with suspected solid pancreatic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations agree to participate in the research and be able to sign informed consent.
  • Patients with no prior history of treatment for pancreatic lesions.

Exclusion Criteria7

  • Patients with absolute contraindications to EUS examination.
  • Pregnancy or lactating.
  • Uncorrectable coagulopathy(PTT>50 seconds or INR>1.5) and/or uncorrectable thrombocytopenia(platelet count<50×109/L).
  • Upper gastrointestinal obstruction.
  • Patients who underwent surgical treatment or anatomical alterations of the pancreas due to lesions in other thoracic and/or abdominal organs, as well as patients with congenital anatomical abnormalities.
  • Patients who have undergone biliary/pancreatic duct stent placement.
  • Patients who refuse to sign the informed consent.

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Interventions

DEVICEiEUS-SPL(intelligent endoscopic ultrasound system-pancreatic solid lesion)

The iEUS-SPL will automaticly detect solid pancreatic lesions and integrate the patients' endoscopic ultrasound images, endoscopic ultrasound features, clinical data and imaging features to perform a five-category classification for the lesions, categorizing them as pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis and chronic pancreatitis.


Locations(1)

Qilu Hospital of Shandong University

Jinan, Shandong, China

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NCT07381192


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