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.
This multicenter, prospective cohort study aims to develop and validate a multimodal artificial intelligence system named iEUS-PCL for the detection and differential diagnosis of PCL. The model was developed based on retrospectively collected EUS images, EUS features, clinical data and radiological imaging features of patients who underwent EUS examination. The diagnostic performance of iEUS-PCL will be evaluated prospectively in real-time EUS videos and compared with endosonographers' performance.
Study Type
OBSERVATIONAL
Enrollment
176
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.
Qilu Hospital of Shandong University
Jinan, Shandong, China
RECRUITINGThe accuracy of iEUS-PCL for pancreatic cystic lesions
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).
Time frame: During procedure
The sensitivity of iEUS-PCL for pancreatic cystic lesions
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).
Time frame: During procedure
The specificicy of iEUS-PCL for pancreatic cystic lesions
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).
Time frame: During procedure
The postive predictive value of iEUS-PCL for pancreatic cystic lesions
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).
Time frame: During procedure
The negative predictive value of iEUS-PCL for pancreatic cystic lesions
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).
Time frame: During procedure
Comparison of the accuracy between iEUS-PCL and endosonographers
The secondary outcome of the study is to comparing the accuracy between iEUS-PCL and different-level endosonographers in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
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Time frame: During procedure
Comparison of the sensitivity between iEUS-PCL and endosonographers
The secondary outcome of the study is to comparing the sensitivity between iEUS-PCL and different-level endosonographers in identifying in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
Time frame: During procedure
Comparison of the specificity between iEUS-PCL and endosonographers
The secondary outcome of the study is to comparing the specificity between iEUS-PCL and different-level endosonographers in identifying in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
Time frame: During procedure
Comparison of the postive predictive value between iEUS-PCL and endosonographers
The secondary outcome of the study is to comparing the postive predictive value between iEUS-PCL and different level endosonographers in identifying in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
Time frame: During procedure
Comparison of the negative predictive value between iEUS-PCL and endosonographers
The secondary outcome of the study is to comparing the negative predictive value between iEUS-PCL and different-level endosonographers in identifying in identifying the pancreatic cystic lesions (benign/malignant; mucinous/non-mucinous; 4-category).
Time frame: During procedure