This prospective, international, multicenter observational study aims to evaluate the role of Endoscopic Ultrasound-guided Detective Flow Imaging (EUS-DFI) in the characterization of solid pancreatic lesions. The study will assess microvascularization patterns identified by EUS-DFI and their association with the final diagnosis, using histopathology or clinical follow-up as the reference standard. Secondary objectives include evaluating interobserver agreement and the diagnostic accuracy of DFI vascular patterns for differentiating benign and malignant pancreatic lesions.
Endoscopic ultrasound (EUS) is an essential technique for the evaluation of pancreatic lesions. However, conventional B-mode imaging alone is often insufficient to accurately differentiate the various types of solid pancreatic tumors, making tissue acquisition necessary in many cases. Despite the high diagnostic accuracy of EUS-guided sampling, false-negative results may occur and repeated sampling can be required. Detective Flow Imaging (DFI) is a novel ultrasound technology that enables visualization of microvascularization without the use of contrast agents by detecting low-velocity blood flow while minimizing motion artifacts. Preliminary evidence suggests that DFI may improve lesion characterization, but data regarding its application in solid pancreatic lesions remain limited. This is a prospective, international, multicenter observational study including adult patients undergoing routine EUS in whom a solid pancreatic lesion is identified. All participants will undergo standard EUS evaluation, EUS-guided DFI assessment, and tissue acquisition according to routine clinical practice. DFI findings will be correlated with the final diagnosis established by surgical pathology, EUS-guided tissue sampling, or comprehensive clinical, imaging, and laboratory follow-up of at least six months. The primary objective is to characterize DFI microvascularization patterns according to the histological diagnosis of solid pancreatic lesions. Secondary objectives include assessing interobserver agreement among investigators and determining the diagnostic performance of DFI vascular patterns for differentiating malignant from benign pancreatic lesions.
Study Type
OBSERVATIONAL
Enrollment
48
DFI vascularization pattern
Classification of vascularization pattern as hypovascular, isovascular, hypervascular or indeterminate on DFI.
Time frame: At the time of the EUS procedure
Presence of vessels
Presence or absence of vessels identified on DFI.
Time frame: At the time of the EUS procedure
Vessel distribution
Classification of vessel distribution as intratumoral or peritumoral on DFI.
Time frame: At the time of the EUS procedure
Interobserver agreement for DFI vascular pattern classification
To assess the interobserver agreement among investigators for the classification of DFI vascular patterns.
Time frame: Up to 6 months
Diagnostic accuracy of DFI vascular patterns for malignancy
To evaluate the diagnostic accuracy of DFI vascular patterns for differentiating benign and malignant solid pancreatic lesions using the final diagnosis as the reference standard.
Time frame: Up to 6 months
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