hepatocellular carcinoma liver cyst hemangioma focal fatty sparing focal fatty infiltration hepatocellular carcinoma focal liver lesion ultrasonography artificial intelligence deep learning convolutional neural network computer aided screening and surveillance
Conditions
Interventions
Non-expert operators will perform ultrasound examinations with AI assistance.,Non-expert operators will perform ultrasound examinations without AI assistance.,Expert operators will perform ultrasound
Experimental Other,No Intervention Other,Experimental Other,No Intervention Other
Non-expert operators with AI assistance,Non-expert operators without AI assistance,Expert operators with AI assistance,Expert operators without AI assistance
Sponsors
Chulalongkorn University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients who meet diagnostic criteria of the following focal liver lesions: 1. Hepatocellular carcinoma (HCC). Pathology results will be considered first. If there is no pathology result, CT and/or MRI results within 3 months before or after the index ultrasound date will be considered. 2. Liver cysts. Simple cysts can be diagnosed solely by ultrasound. However, diagnosis of complicated cysts requires confirmatory CT and/or MRI. Additionally, size of the lesion must also be stable during at least 2-year interval. 3. Hemangioma. CT/MRI results will be used as gold standard for diagnosis. If there is no CT/MRI, typical hemangioma (round homogeneous bright hyperechoic lesion on ultrasound) can be diagnosed by follow-up criteria, i.e., at least 2 ultrasound studies demonstrating size stability during at least 2-year interval. 4. Focal fatty sparing. CT/MRI will be considered first. If there is no CT/MRI, ultrasound diagnosis will be accepted only if the lesion has typical shape (geographic-shaped homogeneous hypoechoic lesion), and is located in typical area of the liver (peri-portal or peri-gallbladder). Size of the lesion must also be stable during at least 2-year interval. 5. Focal fatty infiltration. CT/MRI will be considered first. If there is no CT/MRI, ultrasound diagnosis will be accepted only if the lesion has typical shape (geographic-shaped homogeneous hyperechoic lesion), and is located in typical area of the liver (peri-portal or peri-gallbladder). Size of the lesion must also be stable during at least 2-year interval. Patients without focal liver lesions, by one of the following criteria: 1. has CT/MRI within 6 months before or after ultrasound performing in the study arms, confirming that there is no focal liver lesion. 2. At least 2 ultrasound studies demonstrating no focal liver lesion, with at least one ultrasound study performed within 6 months before or after ultrasound performing in the study arms.
Exclusion criteria
Exclusion criteria: 1. Patients with polycystic liver disease 2. HCCs previously treated by locoregional methods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| detection rate of focal liver lesions after enrollment is completed detection rate | — |
Secondary
| Measure | Time frame |
|---|---|
| false positive detections of focal liver lesions after enrollment is completed false positive detections,detection rates stratified by diagnoses of focal liver lesions after enrollment is completed detection rate | — |
Countries
Thailand
Contacts
Public ContactRoongruedee Chaiteerakij
Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University
Outcome results
None listed