EUS-DFI in Solid Pancreatic Lesions
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJulio Iglesias García
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 years or older.
Presence of a solid pancreatic lesion identified during endoscopic ultrasound (EUS), regardless of the indication for the examination.
Ability and willingness to provide written informed consent.
Disqualifiers
Predominantly cystic pancreatic lesions.
Anatomical abnormalities preventing adequate EUS examination.
Limited ability to understand the study procedures or provide informed consent.
Refusal to sign the informed consent form.
Trial population
Adult patients undergoing routine endoscopic ultrasound (EUS) in participating centers in whom a solid pancreatic lesion is identified and who provide written informed consent.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
DFI vascularization pattern
Classification of vascularization pattern as hypovascular, isovascular, hypervascular or indeterminate on DFI.
Time frame
At the time of the EUS procedure2
Presence of vessels
Presence or absence of vessels identified on DFI.
Time frame
At the time of the EUS procedure3
Vessel distribution
Classification of vessel distribution as intratumoral or peritumoral on DFI.
Time frame
At the time of the EUS procedureSecondary outcomes
1
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 months2
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 monthsLocations
Sponsors and contacts
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Julio Iglesias García
Lead sponsor
Hospital Clinico Universitario de Santiago
Sponsor institution
Ospedale San Raffaele, Università Vita Salute San Raffaele
Collaborator
Policlinico Universitario Campus Bio-Medico
Collaborator
Leids Universitair Medisch Centrum (LUMC), Leiden
Collaborator
Source ClinicalTrials.gov
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