EUS-DFI in Solid Pancreatic Lesions

NCT07763561 | Not Yet Recruiting

• 1 other identifier: EUS-DFI 2025/01
• Study Type: observational
• Target: 48
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pancreatic Neoplasms; Pancreatic Solid Lesions

Outcome Measures

Primary Outcomes (3)

• DFI vascularization pattern

  Classification of vascularization pattern as hypovascular, isovascular, hypervascular or indeterminate on DFI.

  At the time of the EUS procedure

• Presence of vessels

  Presence or absence of vessels identified on DFI.

  At the time of the EUS procedure

• Vessel distribution

  Classification of vessel distribution as intratumoral or peritumoral on DFI.

  At the time of the EUS procedure

Secondary Outcomes (2)

• Interobserver agreement for DFI vascular pattern classification

  Up to 6 months

• Diagnostic accuracy of DFI vascular patterns for malignancy

  Up to 6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Julio Iglesias García: lead
• Ospedale San Raffaele, Università Vita Salute San Raffaele: collaborator
• Policlinico Universitario Campus Bio-Medico: collaborator
• Leids Universitair Medisch Centrum (LUMC), Leiden: collaborator

Related Publications (3)

• Miwa H, Sugimori K, Yonei S, Yoshimura H, Endo K, Oishi R, Funaoka A, Tsuchiya H, Kaneko T, Numata K, Maeda S. Differential Diagnosis of Solid Pancreatic Lesions Using Detective Flow Imaging Endoscopic Ultrasonography. Diagnostics (Basel). 2024 Apr 24;14(9):882. doi: 10.3390/diagnostics14090882.

  PMID: 38732296 BACKGROUND

• Mulqui MV, Caillol F, Ratone JP, Hoibian S, Dahel Y, Meunier E, Archimbaud C, Giovannini M. Detective flow imaging versus contrast-enhanced EUS in solid pancreatic lesions. Endosc Ultrasound. 2024 Jul-Aug;13(4):248-252. doi: 10.1097/eus.0000000000000076. Epub 2024 Aug 23.

  PMID: 39318752 BACKGROUND

• Yamashita Y, Kitano M. Role of contrast-enhanced harmonic endoscopic ultrasonography (EUS) and EUS elastography in pancreatic lesions. Clin Endosc. 2024 Mar;57(2):164-174. doi: 10.5946/ce.2023.074. Epub 2024 Jan 17.

  PMID: 38229442 BACKGROUND

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Julio Iglesias García, PhD

  Hospital Clínico Universitario de Santiago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julio Iglesias García, PhD

CONTACT

981951364; dig.chus.santiago@sergas.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Endoscopy Unit

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: August 13, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 13, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share