iEUS-PCL(intelligent endoscopic ultrasound system- pancreatic cystic lesion): The iEUS-PCL will automatically detect pancreatic cystic lesions and integrate the patients' EUS images, EUS features, clinical data and radiological imaging features to perform three classification tasks:
1. binary classification: benign/malignant lesions;
2. binary classification: mucinous/non-mucinous lesions;
3. four-category classification: intraductal papillary mucinous neoplasm/ mucinous cystic neoplasm/ serous cyst neoplasm/ pancreatic cyst.
Study summary
The aim of this study is to develop and validate an artificial intelligence system named iEUS-PCL (intelligent endoscopic ultrasound system-pancreatic cystic lesions） for detecting and multimodal, multi-class diagnosing pancreatic cystic lesions (PCL) during endoscopic ultrasound (EUS) examination.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Patients aged ≥18 years scheduled for EUS with suspected pancreatic cystic lesions based on clinical symptoms, medical history, laboratory tests or radiological examinations, and who agree to participate in the research and voluntarily sign the informed consent.
2. Patients with no prior history of treatment for pancreatic lesions.
Exclusion Criteria:
1. Patients with absolute contraindications to EUS examination.
2. Pregnancy or lactating.
3. Uncorrectable coagulopathy (PTT\>50 seconds or INR\>1.5) and/or uncorrectable thrombocytopenia(platelet count\<50×109/L).
4. Upper gastrointestinal obstruction.
5. 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.
6. Patients who have undergone biliary/pancreatic duct stent placement.
7. Patients who refuse to sign the informed consent.
Primary outcome measure(s)
The accuracy of iEUS-PCL for pancreatic cystic lesions — During procedure The primary outcome of the study is to evaluate the accuracy of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
The sensitivity of iEUS-PCL for pancreatic cystic lesions — During procedure The primary outcome of the study is to evaluate the sensitivity of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
The specificicy of iEUS-PCL for pancreatic cystic lesions — During procedure The primary outcome of the study is to evaluate the specificity of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
The postive predictive value of iEUS-PCL for pancreatic cystic lesions — During procedure The primary outcome of the study is to evaluate the postive predictive value of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
The negative predictive value of iEUS-PCL for pancreatic cystic lesions — During procedure The primary outcome of the study is to evaluate the negative predictive value of the iEUS-PCL in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
Trial sites (1)
Facility
City
Region
Status
Qilu Hospital of Shandong University
Jinan
Shandong
Recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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