Pancreatic Cystic Lesion (PCL)
Conditions
Keywords
endoscopic ultrasound, pancreatic cystic lesion, machine learning
Brief 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.
Detailed description
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.
Interventions
DEVICEiEUS-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.
Sponsors
Qilu Hospital of Shandong University
Liaocheng People's Hospital
Taian City Central Hospital
Qilu Hospital of Shandong University (Qingdao)
Binzhou People's Hospital
Shandong Provincial Hospital
The Affiliated Hospital of Qingdao University
Qianfoshan Hospital
Shengli Oilfield Hospital
Binzhou Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the sensitivity between iEUS-PCL and endosonographers | During procedure | 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). |
| Comparison of the specificity between iEUS-PCL and endosonographers | During procedure | 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). |
| Comparison of the postive predictive value between iEUS-PCL and endosonographers | During procedure | 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). |
| Comparison of the negative predictive value between iEUS-PCL and endosonographers | During procedure | 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). |
| Comparison of the accuracy between iEUS-PCL and endosonographers | During procedure | 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). |
Countries
China
Contacts
CONTACTZhen Li
Outcome results
None listed