Non-hypovascular Solid Pancreatic Lesions: Role of EUS (LE-VASC)

Role of EUS in Differential Diagnosis and Malignancy Prediction of Non-hypovascular Solid Pancreatic Lesions: A Prospective Observational Study

Vascular pattern of solid pancreatic lesions (SPLs) has been investigated by different abdominal imaging modalities and by contrast-enhanced endoscopic ultrasonography (CE-EUS). Compared with surrounding pancreatic parenchyma three different patterns have been described: hypo-, iso-, and hypervascular. The majority of SPLs are hypovascular, and the diagnostic relevance of hypoenhanced pattern to predict pancreatic adenocarcinoma (PDAC) is well established. Differently, iso- and hypervascular pattern is not specific and can be expressed by several SPLs, with different clinical behavior and management. To date, poor is know about the role of EUS in differential diagnosis of non-hypovascular SPLs and features associated with malignancy.

Study Overview

• Status: Completed
• Conditions: Endoscopic Ultrasound; Solid Pancreatic Neoplasms
• Intervention / Treatment: Diagnostic test: Endoscopic ultrasound-fine needle biopsy

• Study Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• Italy
  • VR
    • Verona, VR, Italy, 37138
      • Stefano Francesco Crinò

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All consecutive patients fulfilling inclusion and exclusion criteria will be included in the study.

Description

Inclusion Criteria:

• Presence of one or more solid pancreatic lesions preliminary evaluated by contrast-enhanced computed tomography (CE-CT) and/or contrast enhanced magnetic resonance imaging (CE-MRI) reporting a non-hypovascular contrast pattern (e.g., iso- or hypervascular).

Exclusion Criteria:

• Patients with associated chronic pancreatitis features (e.g., pancreatic calcifications)
• Lesion with hypovascular pattern at CE-EUS.
• Lesion not found or non pancreatic at EUS.
• Patients refusing to be included in the study

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upstream dilation of the main pancreatic duct	Percentage of cases with upstream dilation of main pancreatic duct will be recorded.	6 months
Vascular pattern (iso or hypervascular)	Percentage of cases with iso-vascular or hyper-vascular pattern will be recorded.	6 months
Lesion borders (smooth or irregular)	Percentage of cases with smooth or irregular borders will be recorded.	6 months

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: November 8, 2018
• First Submitted That Met QC Criteria: November 9, 2018
• First Posted (Actual): November 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 5, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: 1296CESC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No