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Clinical Trials/NCT03738280
NCT03738280
Completed
Not Applicable

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

Azienda Ospedaliera Universitaria Integrata Verona1 site in 1 country154 target enrollmentMay 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Solid Pancreatic Neoplasms
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Enrollment
154
Locations
1
Primary Endpoint
Upstream dilation of the main pancreatic duct
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 1, 2016
End Date
May 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Stefano Francesco Crinò, MD

Principal Investigator

Azienda Ospedaliera Universitaria Integrata Verona

Eligibility Criteria

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

Outcomes

Primary Outcomes

Upstream dilation of the main pancreatic duct

Time Frame: 6 months

Percentage of cases with upstream dilation of main pancreatic duct will be recorded.

Lesion borders (smooth or irregular)

Time Frame: 6 months

Percentage of cases with smooth or irregular borders will be recorded.

Vascular pattern (iso or hypervascular)

Time Frame: 6 months

Percentage of cases with iso-vascular or hyper-vascular pattern will be recorded.

Study Sites (1)

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