EUS-DFI in Solid Pancreatic Lesions

Role of Endoscopic Ultrasound-guided Detective Flow Imaging (EUS-DFI) for the Evaluation of Solid Pancreatic Tumours: A Prospective, International Multicenter Study

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07763561

Acronym

DFI

Enrollment

Registered

2026-08-13

Start date

2026-12-01

Completion date

2027-12-31

Last updated

2026-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms, Pancreatic Solid Lesions

Brief summary

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.

Detailed description

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
DFI vascularization pattern	At the time of the EUS procedure	Classification of vascularization pattern as hypovascular, isovascular, hypervascular or indeterminate on DFI.
Presence of vessels	At the time of the EUS procedure	Presence or absence of vessels identified on DFI.
Vessel distribution	At the time of the EUS procedure	Classification of vessel distribution as intratumoral or peritumoral on DFI.

Secondary

Measure	Time frame	Description
Interobserver agreement for DFI vascular pattern classification	Up to 6 months	To assess the interobserver agreement among investigators for the classification of DFI vascular patterns.
Diagnostic accuracy of DFI vascular patterns for malignancy	Up to 6 months	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.

Contacts

CONTACTJulio Iglesias García, PhD

dig.chus.santiago@sergas.es981951364

PRINCIPAL_INVESTIGATORJulio Iglesias García, PhD

Hospital Clínico Universitario de Santiago

Outcome results