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OpenTrials
Completed

NCT Number: NCT03738280

Non-hypovascular Solid Pancreatic Lesions: Role of EUS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Stefano Francesco Crinò

Verona, VR, 37138, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic ultrasound-fine needle biopsy

Diagnostic Test

Patients with non-hypovascular solid pancreatic lesion undergo endoscopic ultrasound-fine needle biopsy

Primary outcomes

  1. Upstream dilation of the main pancreatic duct

    Time frame: 6 months

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

  2. Vascular pattern (iso or hypervascular)

    Time frame: 6 months

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

  3. Lesion borders (smooth or irregular)

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera Universitaria Integrata Verona

Other

Registry information

Official study title

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

Acronym: LE-VASC

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Nov 13, 2018
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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