Non-hypovascular Solid Pancreatic Lesions: Role of EUS

NCT03738280 | Completed

• 1 other identifier: 1296CESC
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Pancreatic Neoplasms; Endoscopic Ultrasound

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Endoscopic ultrasound-fine needle biopsy DIAGNOSTIC_TEST

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

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Integrata Verona: lead

Study Sites (1)

Stefano Francesco Crinò

Verona, VR, 37138, Italy

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2018
• First Posted: November 13, 2018
• Study Start: May 1, 2016
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)