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.
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.
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.
Adult patients with suspected solid pancreatic lesions undergoing EUS.
Cohort
Prospective
iEUS-SPL(intelligent endoscopic ultrasound system-pancreatic solid lesion)
DeviceThe 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.
The accuracy of iEUS-SPL for solid pancreatic lesions
The primary outcome of the study is to evaluate the accuracy of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
The sensitivity of iEUS-SPL for solid pancreatic lesions
The primary outcome of the study is to evaluate the sensitivity of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
The specificicy of iEUS-SPL for solid pancreatic lesions
The primary outcome of the study is to evaluate the specificity of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
The postive predictive value of iEUS-SPL for solid pancreatic lesions
The primary outcome of the study is to evaluate the postive predictive value of the iEUS-SPL in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
Comparison of the accuracy between iEUS-SPL and endosonographers
The secondary outcome of the study is to comparing the accuracy between iEUS-SPL and different-level endosonographers in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
Comparison of the sensitivity between iEUS-SPL and endosonographers
The secondary outcome of the study is to comparing the sensitivity between iEUS-SPL and different-level endosonographers in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
Comparison of the specificity between iEUS-SPL and endosonographers
The secondary outcome of the study is to comparing the specificity between iEUS-SPL and different-level endosonographers in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
Comparison of the postive predictive value between iEUS-SPL and endosonographers
The secondary outcome of the study is to comparing the postive predictive value between iEUS-SPL and different-level endosonographers in identifying the solid pancreatic lesions (including pancreatic cancer, pancreatic neuroendocrine tumor, solid pseudopapillary tumor, autoimmune pancreatitis, chronic pancreatitis).
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Qilu Hospital of Shandong University
Lead sponsor
Liaocheng People's Hospital
Collaborator
Taian City Central Hospital
Collaborator
Qilu Hospital of Shandong University (Qingdao)
Collaborator
Binzhou People's Hospital
Collaborator
Shandong Provincial Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Qianfoshan Hospital
Collaborator
Shengli Oilfield Hospital
Collaborator
Binzhou Medical University
Collaborator
