Endoscopic Ultrasound (EUS), Solid Pancreatic Lesion
Conditions
Keywords
endoscopic ultrasound, solid pancreatic lesion
Brief 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.
Detailed description
This is an observational study with a prospective, cohort design. We have developed an artificial intelligence system named iEUS-SPL for multimodal, multi-class diagnosing solid pancreatic lesions using endoscopic ultrasound images, endoscopic ultrasound features, clinical data and imaging features from retrospectively collected patients who underwent EUS. The lesion detection rate and diagnostic performance of iEUS-SPL in identifying solid pancreatic lesions will be evaluated in real-time EUS scanning videos over prospective enrolled cases.
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.
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
Yes
Inclusion criteria
1. 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. 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 accuracy of iEUS-SPL for solid pancreatic lesions | During procedure | 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 | During procedure | 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 | During procedure | 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 | During procedure | 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). |
| The negative predictive value of iEUS-SPL for solid pancreatic lesions | During procedure | The primary outcome of the study is to evaluate the negative 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). |
| the lesion detection rate of iEUS-SPL for detecting solid pancreatic lesions | During procedure | The primary outcome of the study is to evaluate the lesion detection rate of the iEUS-SPL in identifying the solid pancreatic lesions(defined as the number of detected lesions divided by the total number of lesions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the accuracy between iEUS-SPL and endosonographers | During procedure | 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 | During procedure | 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 | During procedure | 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 | During procedure | 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). |
| Comparison of the negative predictive value between iEUS-SPL and endosonographers | During procedure | The secondary outcome of the study is to comparing the negative 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). |
Countries
China
Contacts
CONTACTZhen Li
Outcome results
None listed