Non-hypovascular Solid Pancreatic Lesions: Role of EUS

Endoscopic Ultrasound Clinical Trial

— LE-VASC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03738280
• Other study ID #: 1296CESC
• Status: Completed
• Start date: May 1, 2016
• Est. completion date: May 2019

Study information

• Verified date: May 2019
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: May 2019
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Ultrasound
• Pancreatic Neoplasms
• Solid Pancreatic Neoplasms

Intervention

Diagnostic Test:
• Endoscopic ultrasound-fine needle biopsy
Patients with non-hypovascular solid pancreatic lesion undergo endoscopic ultrasound-fine needle biopsy

Locations

Country	Name	City	State
Italy	Stefano Francesco Crinò	Verona	VR

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona

Country where clinical trial is conducted

Italy, 

Outcome

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